The customer reported to olympus, during a therapeutic electric resection of intestinal polyps procedure, the loop of the single use ligating device could not be released after ligation.The user had to cut the polyp and remove it together from the body with the loop.The procedure was delayed by half an hour and completed using a similar device.There were no reports of patient or user harm associated with this event.
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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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the reported issue was likely caused by the following mechanism: 1) the loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.2) the tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3) since the tube sheath was pulled toward the proximate side, causing the tube to pull the loop.This caused the loop to retract into the coil sheath.As a result, the loop was caught in between the hook and inner surface of the coil, and the loop stopped moving.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ ¿do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ ¿do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ this supplemental report includes a correction to h4.It was confirmed by olympus that the subject device was manufactured in october 2022; however, the exact day in october is unknown.Olympus will continue to monitor field performance for this device.
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