SYNTHES OBERDORF COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Device Inoperable (1663); Defective Component (2292); Failure to Shut Off (2939)
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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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(b)(4).(b)(6).The 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 maintenance, which is user error/misuse/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 by (b)(6) that during service and evaluation, it was observed that the small battery drive device control unit was not functioning and defective.It was noted that the device was stuffed with fluid and had a defective controller and motor.It was also noted that the device failed pre-repair diagnostic tests for the function of the off/oscillation/on switch mode.It was noted in the service order that the device had an unspecified defect.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was 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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Search Alerts/Recalls
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