Model Number URF-V3 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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The metal tube of the bending section was broken, and protruded on the outer surface of the bending section rubber.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus france this phenomenon was attributed to the soldering fixation of the end of the metal braid which was incorporated into the passive bending section came off, and the end of the metal braid was protruded from the bending rubber.The device usage by the user facility may have deviated from operation method described in the instruction manual, which may have caused breakage of soldering section at the end of the metal braid.
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Search Alerts/Recalls
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