SYNTHES OBERDORF OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problems
Detachment Of Device Component (1104); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/06/2014 |
Event Type
malfunction
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper/faulty care and maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported from an unknown location that during service and repair, it was observed that the oscillating saw attachment was found with a gear broken/torn off.This event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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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