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Catalog Number 530.705 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
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 device operating intermittently, 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 battery reamer/drill device was operating intermittently and making an excessive noise.It was further observed that the contact was damaged, and the device had a cosmetic damage because it was worn.It was further determined that the device failed pretest for general condition, check function of device and check power with power test bench.It was noted in the service order that the device was not working properly and so was the forward function.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2022.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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