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 06/21/2021 |
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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the initial reported condition of the device not making any sound at all was not confirmed.Therefore, an assignable root cause was not determined.However, the reported conditions of excessive noise and sticky trigger identified during service and evaluation were confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the moving parts of the trigger did not move smoothly on the small battery drive device and the trigger was sticky.It was further observed that the device had a component damage, cosmetic damage - worn coupling, sharp edges, and made an excessive noise.It was further determined that the device failed pretest for general condition and check for sticky triggers.It was noted in the service order that during a routine check it was discovered that the device did not make any sound at all.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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