Model Number URF-V2 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection of the subject device 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.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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Manufacturer Narrative
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The subject device was returned to sorc.Sorc checked the subject device and found the reported phenomenon.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection of the subject device 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.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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Manufacturer Narrative
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The subject device was returned to sorc.Sorc checked the subject device and found the reported phenomenon.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus service operation repair center (sorc).Olympus medical systems corp.(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, omsc surmised that this 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 stress such as sudden angulation.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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