Non-textile radiolucent retained foreign bodies after surgery have been rarely reported in the literature [3]. Unintentional retained foreign bodies after surgery have the potential to cause serious medical complications for patients and bring fourth serious medico-legal consequences for surgeons and hospitals [1, 3, 4] and are considered "never events" by the National Quality Forum (NQF) and Centers for Medicare and Medicaid Services (CMS) [8, 9]. While strict enforcement of operating room safeguards minimizes the risk of medical errors, the inherent risks of surgery, including the placement of foreign material inside the body, prevents complete elimination of this possibility. It is thought that approximately 1,500 cases of unintentional retained foreign bodies occur in the United States each year [1, 2, 4].
Although the majority of iatrogenic retained foreign bodies are detected soon after surgery [1, 4] others are not detected until many years later [4]. Radiolucent foreign bodies are a particular challenge for detection and require a high index of suspicion. Prevention through instrument inspection and accounting for all radiolucent components used in surgery are the best safeguards to avoid these errors.
Unintentional retained foreign objects after surgery may be asymptomatic or lead to complications including pain, infection, or abscess formation. Occasionally foreign body migration has been noted to result in substantial morbidity [10, 11] and even death [12]. Fortunately, the foreign body in this case was removed without further complication.
Following this event, a root cause analysis was performed to determine the precipitating factors, and to prevent recurrence of this complication. The first issue identified was a process-related error involving surgical equipment modification. In the experience with the Interpulse Powered Lavage System (Stryker, Kalamazoo, MI) at our institution, it was perceived that the irrigation time in operating room was longer than desired. It was also noted that by removing the central "filter cap" in the tip of the irrigator (Figure 7 and Figure 8, white arrow) that a higher flow could be achieved, reducing irrigation time. In operating room time trials this difference was determined to be approximately 45 seconds for each 3-liter bag of saline. Thus, it had become standard practice in our operating rooms to remove this component on the back table, prior to use. However, in light of this event, we have discontinued this practice. We suspect that the central filter cap may add some stability to the fixation of the nozzle tip on the lavage apparatus. Thus, removing this piece may have contributed to the dislodgment of the tip within the pelvic wound. Still, we are not aware of any other events or close-calls with a dislodging irrigator nozzle tip at our institution or in the literature.
While we hope that eliminating this practice of instrument modification will prevent any similar events in the future, we have also instituted several other preventive measures. Because the tip was not a recognized risk for dislodgement and becoming a separate piece, it was not individualized as part of the operative count. Therefore, the second identified root cause issue regards adding lavage nozzle tips to the operative count as an early warning. Additionally, thorough wound inspections will be completed with an increased awareness for the risk of retained instrument components/pieces and nozzle tip dislodgement.
Furthermore, a higher level of suspicion for radiolucent retained foreign bodies will be considered. Undetectable on intraoperative and immediate postoperative imaging, retained radiolucent objects may not be discovered unless the patient becomes symptomatic or unless advanced imaging is ordered. In this case, the diagnosis was not suspected until a discrepancy was noticed on the routine postoperative CT scan. Thus, the incompatibility of radiolucent foreign bodies with standard early detection methods contributed to delayed detection and a return to the operative suite.
Finally, there should be heightened awareness for potential retained foreign bodies with surgical procedures involving large body cavities (abdomen, pelvis, chest) [3] or patients with elevated body mass indices (BMI) [1]. This case included both risk factors, a patient with a BMI of 37.5 and large pelvic wound bed.
Although standard operating room counts, wound explorations and careful intraoperative imaging prevent most unintentional retained foreign bodies, radiolucent foreign bodies are a particular challenge for detection and require a high index of suspicion. We present this case to share awareness for potential pulsatile lavage nozzle tip dislodgement and advise that instrument modification may sacrifice connection integrity. We suggest that particular attention should be paid while utilizing instruments or equipment with radiolucent components in surgery and that instrument components should be individually counted items. We reiterate the importance of standard operating room procedures: time-outs, instrument and sponge counts, wound inspection and careful assessment of intraoperative/postoperative imaging.