This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated it was determined that functionally the device stopped by itself, and there was an internal finding that the sliding sleeve was sealed incorrectly.It was noted that the was a lot of fluid found in the mechanism due to a damaged gasket.Therefore, the reported condition was confirmed.However, the assignable root cause was not determined.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi ¿ (b)(4).
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It was reported from the (b)(6) that the battery oscillator device and battery casing device were defective.It was reported that when more resistance was used on the handpiece device it stopped working.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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