(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 cleaning and handling.This is further defined as misuse, abuse, and possibly user error.If additional information should become available, a supplemental medwatch report will be submitted.
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It was reported by the (b)(6) that during service and evaluation, it was observed that the power module device had liquid malfunction.It was noted that the device had no function, the bracket was bent, there was a bulge in groove rear bracket, the indicators were red, and there was liquid residue.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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