As reported in a medwatch report, a scope cap broke off inside of a patient¿s oral cavity and pharynx and needed to be removed with rat tooth forceps.An additional two caps broke but came out with the scope.The event occurred during an gastric peroral endoscopic myotomy (g-poem) under general anesthesia.No additional information regarding the event was provided.The report is linked to patient identifiers: c23574155 (fell in patient), (b)(6) (broke in scope), and (b)(6) (broke in scope).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since the device was not returned to olympus for evaluation, the issue could not be confirmed.Therefore, the root cause of the reported event (device broke off and fell into patient¿s body requiring retrieval) could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, patient or operator injury, malfunction or equipment damage may result.¿ ¿be sure to wipe away any excess lubricant before mounting the instrument and secure the instrument firmly using medical tape with sufficient elasticity.If the instrument is not firmly secured, it could come off inside the body cavity during use and cause patient injury, such as mucous membrane damage.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.
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