The service evaluation confirmed the customer¿s reported issue as the scope was found leaking from the bending section cover which was punctured from a broken/protruding internal metal bending section skeleton.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.
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The service center was informed that the uretero-reno videoscope was returned for service/repair for a reported ¿minor leak¿ found during reprocessing.Upon inspecting, the scope was found leaking from the bending section cover which was punctured from a broken/protruding internal bending section skeleton.This report is being submitted to capture broken/protruding internal bending section skeleton.No death, injury or harm was reported.
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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.Based on the results of the investigation, the following likely caused the event: user applied excessive stress to the bending section and the bending tube was broken.The root cause of why the device was excessively stressed could not be determined.The following is included in the ifu and may have helped prevent the event: "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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