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Catalog Number 05.001.201 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2020 |
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition was not confirmed.However during evaluation, it was noted that the device trigger was fractured and sticky.It was further determined that the device failed pretest for check for sticky triggers and general condition.The assignable root cause was traced to component failure due to normal wear.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 handpiece device trigger was fractured and sticky.It was further determined that the device failed pretest for check for sticky triggers and general condition.It was noted in the service order that the device did not have enough energy to cut the bone.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The date of event was unknown, but was known to have occurred in 2020.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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