The device was returned for investigation.Upon evaluation of the device, forceps cover glue peeling and bending section cover crack were noted.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 5 years since the subject device was manufactured.Based on the results of the investigation, the cause of the forceps cover glue peeling likely occurred from user mishandling the device or physical stress.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "3.2 inspection of the endoscope.5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, peeling, scratches, holes, sagging, transformation, bends, adhesion of foreign body, detached, parts, protruding objects, or any other irregularities.6.Holding the insertion section gently with one hand, carefully run your fingertips over the entire length of the insertion section in both directions.Inspect for any protruding objects or other irregularities.Also confirm that the insertion section is not abnormally stiff." olympus will continue to monitor field performance for this device.
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