SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Unintended System Motion (1430); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had intermittent operation and unintended activation/motion.Therefore, the reported condition that the device had an undetermined malfunction was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.(b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the small battery drive device had insufficient/low power, a worn motor, intermittent operation, and unintended activation/motion.It was further determined that the device failed pretest for check for unintended motion and check the power with the test bench.It was noted in the service order that the device had an undetermined malfunction.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 the event was not reported, however, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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