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, and also found that there was damage (hole) in the instrument channel.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from sorc, osmc surmised that this phenomenon was attributed to the user's insufficient reprocessing of the subject device and/or the user handling.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 the service department of olympus service operation repair center (sorc), it was found that the foreign material came out from the exit of the instrument channel of the subject device.The subject device was loaner asset of olympus.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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