Surgical Errors and Retained Foreign Objects: Causes, Liability, and the Path to Zero Never Events

Surgical Errors & Retained Foreign Objects (RFO/RSI): What They Are

Surgical errors are preventable mistakes that occur before, during, or after an operation and fall below accepted standards of care. Among the gravest are retained foreign objects—also called retained surgical items (RSI)—when items such as sponges, gauze, instruments, needles, guidewires, or fragments are unintentionally left inside the body after wound closure.

RFOs are typically classified as “never events” because they should not occur with proper protocols. They can cause infection, pain, organ perforation, bowel obstruction, fistula, sepsis, and the need for additional surgeries. Although reported incidence varies due to under-reporting, medical literature consistently places RFOs among the most frequent never events in the operating room.

How RFOs Happen: System Failures, Not Just Individual Mistakes

RFO cases nearly always reflect system breakdowns rather than a single bad actor. Contributing factors include inadequate counts, communication gaps, deviation from checklists, workflow interruptions, and poor safety culture.

High-Risk Scenarios

• Emergency or unplanned procedures with time pressure and incomplete setup.
• Procedure changes or multi-team handoffs (e.g., trauma + vascular + general surgery).
• Large blood loss, difficult exposure, or long operative times.
• Obesity or deep cavities where visualization is reduced.
• Multiple sponges/instruments in use, limited staff, or staff turnover during the case.

Where Counts Fail

• Informal counting or failure to conduct initial, intraoperative, and final counts.
• Counting “assumptions” (accepting a verbal “all there” without verification).
• Documentation gaps—no record of reconciled counts or unresolved discrepancies.
• Overreliance on memory rather than using count boards, barcodes, or RF technology.

Clinical Clues & Complications

Some patients become symptomatic shortly after surgery; others may present months or years later.

• Early: unexplained pain, fever, tachycardia, ileus, wound drainage, abscess on imaging.
• Late: chronic abdominal pain, bowel obstruction, fistula, delayed healing, mass (gossypiboma when a sponge incites granuloma).

Imaging & Diagnosis

• X-ray for radiopaque markers on sponges; limited if marker absent or folded.
• CT/MRI reveals soft-tissue mass with air bubbles, spongiform pattern, or encapsulation.
• Ultrasound for superficial or fluid-filled areas; useful where radiation is undesirable.

Data Snapshot & Trends

While precise numbers vary by study and reporting region, several themes are consistent:

• Sponges account for the majority of RFOs.
• Emergency surgeries carry markedly higher risk than elective cases.
• Counting alone reduces but does not eliminate risk; technology-assisted systems (RFID/barcode) significantly improve detection.

Standards of Care & Patient Safety Protocols

Hospitals and surgical teams are expected to follow a layered safety model. Key elements include:

• WHO Surgical Safety Checklist (sign-in, time-out, sign-out) with explicit item count verification.
• Counting policy: initial, intraoperative, and final counts for sponges, sharps, instruments; documented reconciliation; no closure until discrepancies are resolved.
• Adjunct technology: radiopaque markers, barcode scanning, RF detection wands/mats, standardized count boards visible to the entire team.
• “Cavity sweep” or wound exploration before closure; surgeon calls a “hard stop” when counts disagree.
• Team communication: closed-loop read-backs; empowering any team member to stop the line.

Legal Framework: Negligence & Liability Themes

In many jurisdictions, an RFO is strong evidence of negligence because it rarely occurs absent a breach in protocol. Plaintiffs often proceed under theories such as:

• Deviation from standard of care (failure to count, resolve discrepancies, or image).
• Res ipsa loquitur (the thing speaks for itself): leaving an item is a kind of harm that ordinarily does not occur without negligence and was under the control of the defendants.
• Corporate negligence for institutions that lack policies, training, or technology appropriate to case risk.

Causation links the RFO to injury (e.g., reoperation, infection, pain, lost wages), and damages may include medical expenses, disability, pain/suffering, and, in egregious cases, punitive damages where permitted by law.

Limitations Periods & Discovery Rule

Statutes of limitations often include a discovery rule—the clock may start when the patient discovered or reasonably should have discovered the injury (e.g., when a sponge is finally found on imaging months later). Some jurisdictions also apply a repose statute setting an absolute outer limit. Exact timelines vary and must be verified locally.

Defenses Commonly Raised

• Counts were “correct.” Teams may argue all counts reconciled; plaintiffs counter with technology gaps and failure to sweep or image.
• Comparative fault is rarely applicable in RFOs, but defense may argue intervening events or alternative causes for symptoms.
• Causation disputes (e.g., item left was “inert” vs truly injurious) rebutted by expert testimony.

What Patients Should Do After Suspected RFO

1. Seek medical evaluation immediately for persistent pain, fever, or unusual symptoms after surgery; describe the operation and timeline.
2. Request records: operative report, nursing count sheets, anesthesia record, imaging, incident reports (where obtainable).
3. Preserve evidence: if the object is removed, ask that it be photographed, tagged, and preserved.
4. Record a symptom log: dates, intensity, work impact, and out-of-pocket costs.
5. Consult qualified counsel to analyze deadlines, damages, and expert opinions.

Hospital & Insurer Response: Root-Cause & Remediation

When an RFO is identified, best practice is an immediate “stop the bleed” response:

• Notify leadership, secure the OR documentation, and preserve logs/equipment lists.
• Disclosure to the patient and family; discuss care plan for removal and complications.
• Root-cause analysis (RCA) focusing on process, not blame; implement corrective actions (policy revision, checklist reinforcement, technology adoption, team simulation).
• Event reporting to regulators or accrediting bodies as required; treat as a sentinel event for safety improvement.

Economic Impact & Damages Considerations

RFOs drive repeat hospitalizations, additional anesthesia, extended recovery, and prolonged antibiotic therapy. From a damages perspective, plaintiffs should document medical bills, lost wages/earning capacity, home care costs, and non-economic harms such as pain, mental anguish, and loss of enjoyment. Counsel will often retain medical experts (surgery, infectious disease, radiology) and economists/vocational experts to quantify losses.

Prevention Playbook: From Counting to Tech-Enabled Safety

Mandatory Core Practices

• Standardized count policy with documented initial, intra-, and final counts.
• Time-out and sign-out explicitly address item reconciliation before closure.
• Visual count boards and two-person verification for high-risk items.
• Cavity sweep + irrigation + systematic field inspection prior to final closure.

Technology Adjuncts

• RFID/RF detection sponges with handheld wands/mats to scan the wound.
• Barcode systems for sponges/instruments with autopopulated count logs.
• Radiopaque markers on all soft goods; portable intra-op X-ray when counts disagree.

Practical Timeline Example

Day 0: Emergency laparotomy; sponge count discrepancy noted but “assumed resolved.”
Week 2: Fever and pain; CT shows encapsulated mass consistent with gossypiboma.
Week 3: Reoperation removes RF-negative towel fragment; wound vac and IV antibiotics.
Months 2–4: Lost work time; persistent abdominal wall pain; scar revision later.
Legal window: Discovery rule invoked when CT identified retained item; records and counts obtained; expert review finds deviation from policy and failure to image at closure.

Patient & Family Communication: Trauma-Informed Approach

Beyond clinical harm, RFOs can erode trust. Providers should adopt transparent disclosure, apologize where appropriate under applicable apology laws, explain remediation steps, and ensure psychological support. A respectful process reduces secondary trauma and aligns with ethical duties.

Conclusion: Zero-Harm Goal Is Achievable

Retained foreign objects are emblematic of system failure—but they are also among the most preventable surgical harms. Robust counting protocols, strong team communication, technology adjuncts, and hard-stop culture dramatically reduce risk. For patients and advocates, early recognition, record preservation, and qualified review are essential to both timely care and accountability. Health systems that learn transparently from each event—by redesigning processes rather than assigning blame—move closer to the zero-never-events standard every patient deserves.

Quick Guide

1. Retained foreign objects (RFOs) are classified as “never events” and should never happen if safety systems are functioning.
2. Always ensure all surgical counts are performed—initial, intraoperative, and final.
3. Involve two-person verification for counts and reconciliation before closure.
4. Implement adjunct technology like RFID, barcode systems, and radiopaque materials.
5. Surgeons must conduct cavity sweeps before wound closure.
6. When discrepancies arise, perform intraoperative imaging rather than assumptions.
7. Document every step clearly in the operative report.
8. If symptoms persist post-surgery (pain, fever, abscess), request imaging immediately.
9. Preserve removed items as legal and clinical evidence.
10. Transparency and communication reduce litigation and patient trauma.

FAQ

What does “retained foreign object” mean?

It refers to any unintended item—sponges, needles, or instruments—left inside the patient after surgery, often discovered later through imaging or complications.

How common are these surgical errors?

While exact figures vary, studies estimate 1 in every 5,000 to 7,000 surgeries involves a retained item. Many cases go unreported.

Which surgical items are most frequently left behind?

Sponges and gauze pads account for about 70% of all RFOs, followed by small instruments, needles, and drains.

What symptoms may indicate a retained object?

Persistent post-surgical pain, fever, wound infection, or formation of a palpable mass are common warning signs.

Can imaging always detect a retained object?

Only if the item contains radiopaque markers or if the imaging modality (CT, MRI, ultrasound) identifies the object’s material characteristics.

Who is legally responsible for an RFO?

Typically, the hospital, surgical team, and attending surgeon share liability under negligence or institutional responsibility doctrines.

What legal principle applies to RFO cases?

The doctrine of res ipsa loquitur (“the thing speaks for itself”)—such injuries don’t happen without negligence.

What damages can a patient claim?

Compensation may cover medical costs, additional surgeries, pain and suffering, disability, and sometimes punitive damages depending on jurisdiction.

How can hospitals prevent RFOs?

By enforcing standardized count policies, conducting team briefings, and implementing technology-based tracking systems.

What should a patient do if they suspect a retained item?

Seek immediate medical assessment, request surgical records, preserve removed items, and contact a qualified healthcare or legal professional.

Are these cases reportable to authorities?

Yes. In most countries, retained foreign objects are considered sentinel events that require mandatory reporting and investigation by health authorities.

Legal Foundations

The framework surrounding RFOs comes from medical malpractice law, emphasizing duty of care, breach, causation, and damages. U.S. standards reference:

• Centers for Medicare & Medicaid Services (CMS): classifies RFOs as “never events.”
• Joint Commission Sentinel Event Policy: mandates root-cause analysis and reporting.
• World Health Organization (WHO): Surgical Safety Checklist for count verification and team communication.
• Federal and State Case Law: e.g., Ybarra v. Spangard (1944) establishing res ipsa loquitur in surgical negligence cases.

Hospitals must demonstrate proactive prevention, continuous staff training, and compliance with these national and international safety standards.

Final Considerations

Preventing surgical errors and retained foreign objects depends on strict adherence to protocols, communication among surgical teams, and the use of safety technology. When an event occurs, rapid recognition, ethical disclosure, and appropriate correction protect both patient safety and institutional integrity. A “zero-tolerance for never events” mindset is essential to advancing surgical excellence and restoring public trust.

These materials are for informational purposes only and do not substitute professional medical or legal advice.