Udi - (b)(4).Reporter's phone number: (b)(6).The 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 improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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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 further noted that the coupling was defective, the bearings were worn, the fuse wire was damaged, and the needle screw went through.It was also noted that the device failed pre-repair diagnostic tests for loctite assessment, cable assessment, and safety assessment.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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