(b)(4).(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 maintenance, 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 the motor device was displaying an e6 error code, and was hot during utilization.During service and evaluation it was found that the cable/cord/wiring was damaged, there was liquid damage, the motor and control were defective, there was an e6 error displayed, and the power was too low.It was also noted that the device failed pre-repair diagnostic tests for motor thermistor assessment, handpiece temperature assessment, hand control assessment, and air pump assessment.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.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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