Catalog Number EMAX2-HC |
Device Problems
Mechanical Problem (1384); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/03/2016 |
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 of the spine it was observed that the hand control device was not working with the motor device.It was reported that there was a five minute delay in the procedure as an identical spare hand control device was available for use.It was reported that the procedure was successfully completed.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 identified no failure.Therefore, the reported condition was not confirmed.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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Search Alerts/Recalls
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