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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Device Inoperable (1663); Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the device was powerbroken.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component damage caused by user error / abuse and possibly misuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the motor device locking components were damaged.It was noted in the service order that the device did not work at all, the tool did not stop and the safety lock was defective.This event did not occur during surgery.There was no patient involvement.There were no reports of 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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Search Alerts/Recalls
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