This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of june 2022 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was discarded by the customer.However, based on the results of the investigation, likely mechanisms causing the reported event (loop was difficult to detach from the polyp-loop) include: 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 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.Or 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 or broke because the slider was forcefully operated.(see fig.4) 4) due to above, the loop could not detach from the hook.The following is included in the instructions for use: ¿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¿ on page 3 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 section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 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 section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 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.¿ olympus will continue to monitor field performance for this device.
|