The subject device was received and evaluated.Device evaluation found the reported customer issue was not able to be duplicated.Device was tested and found no issue with suction flow, however, further inspection found the following findings: the elevator channel was found loose.Observed forceps cover glue peeling (c-body), a-rubber glue chipped, leaking and s-cover plate missing.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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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 3 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the forceps cover glue peeling could not be identified.The following is stated in the instructions for use which can help detect the event: "chapter 3 preparation and inspection - 3.2 inspection of the endoscope: 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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