The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the reportable malfunction, the device failed the leak test, the bending section cover had a hole, the bending section cover adhesive was peeling, and the insertion tube had a dent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.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 performed manipulation to apply excessive force to the bending section.As a result, the bending tube was broken and protruded from the a-rubber (bending section cover).However, a definitive root cause could not be determined.The following information is stated in the 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.¿ ¿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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