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Catalog Number 530.710 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
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.Quality engineering evaluated the battery oscillator device, and it was determined that the device failed visual inspections.It was determined that the cause for detached turn knob of the handpiece is a confirmed design error and has been captured in a capa.Also, the cause for other found defects are due to wear.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.Udi ¿ (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 battery oscillator device had contact damage and the mode switch resistance was too low, and the turn knob was detached from the device.It was further determined that the device failed pretest for general condition, check the quick coupling for saw blades, check the function of the device, and mode switch-test.It was noted in the service order that the device would not grip the saw blade.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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