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Catalog Number EMAX2PLUS |
Device Problem
Metal Shedding Debris (1804)
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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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The actual device was returned for evaluation.Reliability engineering evaluated the device 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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Event Description
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It was reported from (b)(6) that the motor device had a metal shaving coming out.The event was not reported to have occurred during surgery.It was not reported if there were any delays due to the event or if a spare device was available.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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Search Alerts/Recalls
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