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Catalog Number 530.610 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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 discovered that the battery oscillator device stopped running when positioned at an angle.There were no delays to the planned surgical procedure.A spare identical device was available for use.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 report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was functioning normally.Therefore, the reported condition of the device stopped running at an angle was not duplicated nor confirmed.An assignable root cause was not determined.However, during evaluation it was observed that the device emitted an unusual sound and had strong vibration, the electric motor was damaged, and that some components were corroded.It was determined that these issues were due to component wear from normal use and servicing over time.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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Search Alerts/Recalls
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