Catalog Number B-TURQ-L_LL |
Device Problems
Break (1069); Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported that the tapered attachment device had bad bearings and was heating up.It was reported that the event did not occur during a surgical procedure.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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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 confirmed.It was determined that the bearings were corroded along with being worn out and no longer in axial alignment not allowing insertion of the cutter.It was determined that if a cutter was able to be inserted and the device was ran, it is highly likely that the device would overheat.The assignable root cause was due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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