SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
Event Type
malfunction
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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 attachment device did not function and was frozen/would not move.It was further determined that the device failed pretest for check the function in running mode, and check oscillation frequency.It was noted in the service order that the equipment was not working.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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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: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was frozen/would not move.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause was determined to be traced to the user, which is user error.Udi: (b)(4).
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Search Alerts/Recalls
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