A user facility returned the olympus, model urf-v3, uretero-reno videoscope to olympus for repair due to a report of an air/water leakage.Upon inspection and testing of the returned device, it was found that a bending rubber defect (broken/torn/ruptured) was present and metal was sticking out.This report is submitted due to the bending rubber defect.As the problem was found during in-house service of the device, there was no patient involvement.
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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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been caused by manipulation by the user which resulted in and application of excessive force to the bending section; then, the bending tube was damaged and protruded from the a-rubber (bending section cover/ distal sheath).Users can detect the suggested event properly by handling the device in accordance with the following instructions for use(ifu)."-precautions: perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.-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.Users can decrease/prevent the suggested event by handling the device in accordance with the following ifu.-do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.-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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