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Catalog Number EMAX2 |
Device Problem
Device Inoperable (1663)
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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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Manufacturer Narrative
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(b)(4).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 motor device stopped working.There were no delays to the planned surgical procedure.A spare device was available for use.The procedure was completed successfully.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the 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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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all operational specifications.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.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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