An olympus representative reported on behalf of the customer that the snare loop of the single use ligating device could not be released during a polypectomy.In addition, the wire was bent and broke, so the operator struggled with the strength of the slider.The wire was cut with a nipper according to the instructions for use and the ligature part was cut using a loop cutter.The procedure was completed with a similar device.The device was inspected prior to use with no issues noted.There was no harm or user injury reported due to the event.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s reported complaint was confirmed.The device evaluation findings are as follows: the sheath was severed at the root of the handle portion.The operating pipe of the slider was broken.The broken portion presented a fracture shape caused by a mechanical load.The broken portion of the sheath presented a shape that was possibly severed by a tool.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, the root cause could not be determined.However, the reported event (loop failed to release) was likely due one of the following mechanisms: mechanism #1: 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 (#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 operating pipe to bend and to break.Mechanism #2: 1) the sheath was bent near the handle.2) the operating wire could not move because sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed and broke because the slider was forcefully operated.4) due to the above, the loop could not detach from the hook.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 in ¿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 in ¿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 in ¿equipment to be used in an emergency¿ in this manual.¿ ¿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.¿ this supplemental report includes an update to d9 and h3.Also, new information has been added to d4 and h4.Olympus will continue to monitor field performance for this device.
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