Model Number CYF-5A |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc for evaluation.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 from the facility that during the preparation for use, it was found that the ¿forceps port¿ of the subject device was detached.Olympus service operation repair center (sorc) checked the subject device and found that the ¿instrument channel port¿, not the ¿forceps port¿ was detached.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.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 service operation repair center (sorc) there was the possibility that the reported phenomenon was attributed to the excessive external force applied to the instrument channel port when attaching or detaching the forceps/irrigation plug to the port.
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Search Alerts/Recalls
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