SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problems
Mechanical Jam (2983); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2020 |
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 this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition 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 oscillating saw attachment device was frozen/would not move.It was further determined that the device failed pretest for check for free moving.It was noted in the service order that the device was not working during pre-surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.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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