Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
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It was reported by (b)(6) that during service and evaluation, it was determined that the cord of the motor device was damaged and there was moisture in the connector.It was further observed that the device generated heat, exhibited vibration, and had a component damage.It was further determined that the device failed pretest for visual assessment, no short circuit between phases and connector body (42), no short circuit between hall sensors and connector body (42), no short circuit between 5vdc line and connector body (42), no short circuit between sensor gnd and connector body (42) and handpiece temperature 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 the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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