The device was returned for investigation.Upon evaluation of the device, forceps cover glue peeling and bending section cover crack were noted.In addition, lose and leaking elevator channel inlet were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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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 over one (1) year since the subject device was manufactured.Based on the results of the investigation, adhesive peeling on the distal end is visible also there was scratches around the area pointed out.We, therefore, cannot rule out the possibility that external force was applied to the relevant part.The following is stated in the instructions for use which can detect the event: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Olympus will continue to monitor field performance for this device.
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