Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to the environment, which is environmental conditions.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 determined that the battery oscillator device was jammed/ seized.It was determined that the device had cosmetic damage, and the moving parts did not move smoothly.It was further determined that the device failed pretest for marking and labeling, general condition, check the battery coupling and trigger test and check the off/ on/ on mode.It was noted in the service order that the device did not work at all.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 the event was unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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