The customer reported to olympus, the uretero-reno videoscope leaked at the bending section.The issue was detected at reprocessing.No patient injury reported.During the evaluation of the device, it was noted the bending section was broken.Metal was protruding from the bending section cover (soldered joints popped out).This report is to capture the reportable malfunction of the bending section was broken.Metal was protruding from the bending section cover (soldered joints popped out) noted at estimation.
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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 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user manipulated the subject device, applying excessive force to the bending section and the bending tube was broken.However, the root cause of the event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ ¿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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