SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Output below Specifications (3004); Noise, Audible (3273); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2022 |
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.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device making an unusual noise was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the sticky trigger, identified during service and evaluation was 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 would not run because the motor was damaged.It was further determined that the device failed pretest for check for sticky triggers, check function of device and check power with power test bench.It was noted in the service order that the device made an unusual noise and lacked torque.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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