Catalog Number 05.001.201 |
Device Problems
Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during an unspecified surgical procedure, it was observed that the handpiece device would not go in reverse.It was reported that there was no delay in the procedure due to the event.It was reported that there was no spare device available for use.There was patient involvement reported.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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The actual device was returned for evaluation.The device was evaluated and the reported condition was not confirmed.An assessment was performed and the device met all manufacture's specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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