The suspect device was returned to olympus and evaluated.The reported problem was confirmed.In addition, the bending section was noted broken due to physical stress and a leak from the biopsy channel was found.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.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.The device history record was unable to be reviewed however, the arp refurbish record was reviewed, and no deviations occurred that could have caused or contributed to the reported issue.Olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that excessive force was applied to the bending section, then the bending tube became broken.The following is included in the instructions for use (ifu): "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, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." "do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged." olympus will continue to monitor field performance for this device.
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