This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.A review of the service history record indicates that the device has been returned previously for an unrelated malfunction.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor device rotations per minute (rpm) were below specification, the hose had a hole, the temperature was above specification and the bearings and cable were damaged.It was further determined that the device failed pretest for hand control assessment, handpiece temperature assessment, air pump assessment, noise assessment, rotational speed assessment, no short circuit between sensor gnd and connector body (42), no short circuit between 5vdc line and connector body (42), no short circuit between hall sensors and connector body (42), no short circuit between phases and connector body (42) and motor thermistor assessment.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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