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.Based on the results of the investigation, the cause of the forceps cover glue peeling likely occurred due to an external force applied to the part.Investigation confirmed that there was no adhesive in the position where adhesive should have been applied.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "inspection of the endoscope 3.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.
|