The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During the evaluation it was found some of the wires that compose the forceps elevator wire were raised due to fraying and a crack on the distal end was evident.Additional findings were as follows: the light cover glass adhesive was worn, the light transmission condition , the optical cover glass adhesive was worn, the outlet pipe was crushed, the distal end cap was damaged, the side view distal end raiser wire was damaged, the control body (air/water housing) colored ring was damaged, the pin unit was corroded, the charge-coupled device wire length was too short, the up/down, the left/right angle all was not to specification, the up/down, the left/right angle all had play.It is most likely that the reported issue was due to user handling.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
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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 root cause of the reported event is unable to be determined.However, the likely cause of the frayed knob wire (k-wire) is due to the following: a cut but not raised k-wire after repeated use was not detected, and the subject device was continued to be used.The cut k-wire got caught in distal cover when attaching the cover during the use, or the cut k-wire interfered with cleaning brush during brushing of the distal end and k-wire is raised.Additionally, the crack on distal end may have occurred due to physical stress such as hitting/dropping the distal end or chemical stress by chemical solutions used.The reported events can be detected by following the instructions for use (ifu) sections: - 3.2 inspection of the endoscope: inspection of the forceps elevator mechanism.- 3.2 inspection of the endoscope: inspection of the endoscope.Olympus will continue to monitor field performance for this device.
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