Surgical Never Event Case Study: Retained Surgical Item (RSI)

Allegation:

The patient alleged that the hospital, clinic, and staff failed to remove a surgical sponge during a femoral popliteal bypass (fem-pop) surgery, resulting in infection, further surgery, prolonged antibiotics, and ongoing medical needs.

Case Details:

A 67 YOM patient with history of peripheral artery disease, chronic obstructive pulmonary disease, hypertension, hyperlipidemia, pulmonary emboli, and DVT presented to the hospital for a fem-pop arterial bypass. The surgery was performed without complications. The pre- and post-operative sponge counts were conducted and were reported as correct by the circulating nurse to the surgeon at the conclusion of the surgery.

Six days later, the patient returned to the hospital with complaints of increasing erythema, edema, and drainage from the thigh incision over the previous three days. The patient was also noted to have cellulitis of the overlying skin. He was found to have a seroma and was taken to surgery the next day for wound exploration. The seroma was evacuated, and the fluid was sent to pathology for a culture, which was negative. The tissue around the graft was surrounded by viable tissue and there didn't appear to be any ongoing infection. During the exploration of the wound, a retained surgical sponge was located deep in the thigh and adjacent to the popliteal artery. The sponge was removed, the wound was irrigated with antibiotics and saline, and closed without difficulty.

Following this second surgery, the surgeon disclosed the retained sponge to the patient and his wife and discussed further treatment options. The options included replacing the bypass graft (requiring a third surgery) or leaving the existing graft in place and providing the patient with long-term antibiotic treatment. The patient chose the latter option and was prescribed six weeks of intravenous (IV) antibiotics. The patient also required a lifetime prescription of oral penicillin due to the potential for future infection. The surgeon continued to treat the patient on an outpatient basis. Ultimately, the wound healed fully within a few months, and the surgeon didn't expect the patient to have any further issues or limitations as a result of the retained sponge.

Upon investigation of the retained sponge, it was determined that the circulating nurse reported an improper sponge count to the surgeon at the end of the surgery and further revealed that the final sponge counts (initial and final) were pre-charted 30 minutes into the surgery, despite the fact the surgery took nearly 2 hours to complete.

Discussion

The surgeon stated that the lifelong use of antibiotics would have been unnecessary had it not been for the retained sponge and the potential for future infection. Even though the wound healed fully and he didn't expect the patient to have any further issues attributable to the retained sponge, the patient may have experienced other issues due to his severe underlying vascular disease. The surgeon further indicated that the patient would have experienced similar issues with his recovery from the original surgery, and it would be difficult to determine how much longer, or more painful the patient’s recovery was due to the second surgery to remove the retained sponge.

The plaintiff was not required to have an expert due to the retained foreign body exception under state common law.

Resolution

Due to the retained sponge requiring additional surgery and the false charting of the staff, the case was settled prior to trial.

Risk Reduction Strategies to Consider^{1,2,3,4,5,6,7,8}

• Do not assume something is being counted. Ask for confirmation from the individuals conducting the counts.
• Do not assume an item is radiopaque. Confirm it with knowledgeable members of the surgical team or leadership.
• If you use a non-radiopaque item, treat it as high risk for retention.
• Perform counts during staff changes in surgeries, including breaks and permanent reliefs.
• Describe specific counting procedure details in policies and protocols.
• Review and revise policies and protocols annually or as needed.
• Include common and additional items on counting forms for use in body cavities.
• Explain retained surgical items (RSI) prevention goals and reasoning during training, especially after changes.
• Incorporate the CUS tool—"Concerned, Uncomfortable, Safety"—into training to further support effective communication and foster a culture of open communication during procedures.
• To avoid allegations of fraud or falsification of medical records, never pre-chart information.
• Document only the facts of the event in the medical record. Never document anywhere that an event will be reported to risk management or that an event report has been completed.

References

1.  The Joint Commission, Patient Safety Advisory Group, “Preventing Unintended Retained Foreign Objects,” Sentinel Event Alert, Issue 51, October 17, 2013.

2. Victoria M. Steelman, et al., “Retained Surgical Sponges: A Descriptive Study of 319 Occurrences and Contributing Factors from 2012 to 2017,” Patient Safety in Surgery 12, 20 (2018), DOI: 10.1186/s13037-018-0166-0.

3.  Agency for Healthcare Research and Quality, “Improving Communication and Teamwork in the Surgical Environment Module: Facilitator Notes,” Content last reviewed May 2017.

4. World Health Organization, “Objective 7: The Team Will Prevent Inadvertent Retention of Instruments and Sponges in Surgical Wounds,” WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives. (PDF)

5. Stanislaw P.A. Stawicki, et al., “Retained Surgical Items: A Problem Yet to Be Solved,” Journal of the American College of Surgeons, 2013 Jan;216(1):15-22. DOI: 10.1016/j.jamcollsurg.2012.08.026.

6. NoThing Left Behind. Prevention of Retained Surgical Items. “All Providers.” (site not accessible at the time of publication)

7.  Verna Gibbs and Patrick Romano, “Retained Surgical Items: Causation and Prevention,” PSNet, Agency for Healthcare Research and Quality, US Department of Health and Human Services. 2025.

8. Atul A. Gawande, et al., "Risk Factors for Retained Instruments and Sponges after Surgery," New England Journal of Medicine, N Engl J Med 2003;348:229-235 vol. 348 no. 3, January 16, 2003, DOI: 10.1056/NEJMsa021721.