The subject device has not been returned to omsc for evaluation but was returned to sorc.Sorc checked the subject device and found the reported phenomenon.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.Based upon the information from sorc, omsc considered that the reported phenomenon was attributed to an excessive twisting operation to the left or right direction with the angulation of the bending section locked, or an irregular load such as sudden angulation.If additional information is received, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair of the subject device at olympus service operation repair center (sorc), it was found that the angulation control knob of the subject device did not move.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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