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Catalog Number 530.100 |
Device Problems
Power Conditioning Problem (1474); Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported from germany that during an unspecified surgery, it was observed that the power drive device did not run frequently and had ¿several dropouts¿.The reporter also stated that there was an ¿abrupt junction¿.There were no delays in the surgical procedure.A spare device was available for use.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).Device manufacture date: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent 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 motor power was too low.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to faulty material.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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