The subject device was not returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.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 olympus (b)(4) and similar past cases, since it is undeniable that the subject device was used with a foreign material on the air/water nozzle, omsc surmised that this phenomenon was attributed to the following.There was a difference between the reprocessing method performed by the user facility and the reprocessing method recommended by the instruction manual.The staff of the user facility had not been trained sufficiently on the handling and reprocessing the subject device according to the instruction manual.If additional information is received, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed from the user that during the unspecified therapeutic gastroscopy using the subject device, it was found the air supply of the subject device was insufficient, which was caused by clogging of the air/water nozzle due to protein coagulation after bleeding of patient.The subject device had been repaired on site by the engineer of the user facility.There was no report of patient injury associated with this event.
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