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Catalog Number 530.710 |
Device Problems
Physical Resistance/Sticking (4012); Premature Separation (4045)
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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.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 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 oscillator device had a sticky trigger, was loose, produced unexpected noise, generated vibration and could not secure/lock cutter.It was noted that the saw blade was loose.It was further determined that the device failed pretest for check the quick coupling for saw blades and check for sticky trigger.It was noted in the service order that during an unspecified surgical procedure the blade came off.It was not reported if there were any delays to the surgical procedure.It was not reported if a spare device was available to complete the surgery.There was 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 available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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