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Catalog Number EMAX2PLUS |
Device Problem
Defective Device (2588)
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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).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to cleaning, sterilization and or maintenance error, which is user error / abuse and possibly misuse.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 by (b)(6) that during service and evaluation, it was discovered that the cable/cord/wiring had a damaged component on the motor device.It was further determined that the motor and control unit were defective.It was noted in the service order that the hand control assessment failed.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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