An olympus representative reported on behalf of the customer that, during a therapeutic colon polyp ligation procedure, the loop of this single use ligating device could not be released after ligation.Temporary tightening was performed because it was difficult to bind the polyp.The user cut the proximal side of the device, removed the scope, reinserted it, and cut it with a loop cutter, then released it.The procedure was 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 and final device evaluation findings.The device was returned to olympus for inspection, and the complete findings are as follows: the operating pipe was broken.The broken portion exhibited the shape of ductile fracture.The sheath near the handle was severed by something like a tool.The loop was not connected to the hook and not returned for investigation.The hook presented no abnormalities such as deformation or bending.Other abnormalities that could lead to the reported event were not confirmed.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, a mechanism that likely caused the reported event is as follows: 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 the 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 forcibly operated in state of ¿6¿ description.This had caused the operation pipe to bend and to break.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 section 12, ¿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 remove.In this case, refer to section 12, ¿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 remove.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ ¿never use excessive force to operate the instrument.This could damage the instrument.¿ olympus will continue to monitor field performance for this device.
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