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Catalog Number LONG_LL |
Device Problems
Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that it was difficult to insert the cutter device due to the bearings being worn out and no longer in axial alignment not allowing the insertion of the cutter device.It was determined that this was due to wear from normal use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during routine inspection, it was observed that there was black debris coming out of the distal end on the attachment device while it was running.There were no delays to a surgical procedure.It was unknown if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of event was not provided.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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