The evaluation found a broken metal wires protruding from the insertion tube.The angulation is below specifications.The device was repaired and returned to the customer.A review of the repair history shows the customer indicates no previous repair records; purchased pm september 7, 2019.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
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This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.A review of the repair history indicated that the device has not been repaired in the past year.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned to the legal manufacturer for evaluation, therefore the exact cause of the reported malfunction could not be conclusively determined.The reported malfunction is a known issue.To prevent adverse event, the legal manufacturer changed the design of the bending tube to prevent injury inside of patient body even if bending tube gets broken.Based on similar investigations, the potential cause of the reported malfunction is due to the user¿s manipulation so as to apply excessive stress to the bending section may have caused the bending tube to break and protrude out the bending section cover.As stated on the ifu (instruction for use) and as a preventative measure, the ifu states the following: 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 complaints for this device.
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