SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Noise, Audible (3273); Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2021 |
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.The small battery drive device was evaluated and the reported condition that the device had no power was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the had a sticky trigger and was making excessive noise.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.Udi: (b)(4).
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Event Description
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It was reported from the (b)(6) that during service and evaluation, it was determined that the small battery drive device had component damage, a sticky trigger, was making excessive noise, and had a worn coupling.It was further determined that the device failed pretest for general condition, check the attachment coupling, and check for sticky triggers.It was noted in the service order that the device had no power.This event did not occur during 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 will be submitted accordingly.
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Search Alerts/Recalls
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