The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from sorc, there was the possibility that the reported phenomenon was attributed to the angulation with the excessive force while the bending section was locked, or the twisting of the insertion section with the excessive force, and so on.If additional information becomes available, this report will be supplemented.
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Olympus medical systems corp, (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc), it was found that the bending section cover of the subject device had been torn and the broken internal metal part had been sticking out from the inside of bending section cover of the subject device.There was no report of patient injury associated with this event.
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