Model Number URF-V |
Device Problems
Break (1069); Fracture (1260)
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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 subject device was not returned to 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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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the repair center of olympus (b)(4) (oekg), it was found that the bending section of the subject device was broken.The repair center also found that there was a leakage from the bending rubber, and the universal cord was deformed and scratched.There was no report of patient injury associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device evaluation result.The subject device was not 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 event could not be conclusively determined.However, based on the information from olympus europa k.G (oekg), there was the possibility that this phenomenon was attributed to the external force.Olympus stated the appropriate handling of urf-v and the counter measures against abnormalities in the instruction manual of urf-v.
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Search Alerts/Recalls
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