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Catalog Number 530.610 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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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 motor seized and was running rough.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to 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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Event Description
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It was reported by (b)(6) that when in use, it was observed that the battery oscillator device stopped working and switched off.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.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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(b)(6).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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Search Alerts/Recalls
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