The customer reported to olympus that during the therapeutic colonoscopy, the loop of the single use ligating device was placed around a large polyp and tightened, but it would not disengage from the applicator.The outer wire had to be cut and uncoiled to expose the inner sheath so the loop could be advanced all the way out.There was a less than 10 minute procedural delay as a result of the issue.The loop cutter was replaced, and the procedure was completed.No further additional medical/surgical intervention was needed.The issue did not impact the outcome of the procedure and there was no patient harm or injury.The device was inspected before use and appeared normal.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide corrections to the initial (d9, h3, and h4).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.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, it is likely the mechanism causing the reported event might be the following: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in state of above description 2).Therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) the hook was pulled.This caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.7) the slider was forcefully operated in state of ¿6¿ description.This had caused the operation pipe to bend and to break.However, the root cause of the reported event could not be identified.The event can be prevented by following the instructions for use 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 section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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 section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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 section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "never use excessive force to operate the instrument.This could damage the instrument." "straighten out the portion of the instrument that extends from the biopsy valve." in addition, the following non-reportable malfunctions were found during the device evaluation: distal end of the sheath was broken and part of the applicator falls into the endoscope channel.Olympus will continue to monitor field performance for this device.
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