Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.However, the assignable root cause could not be determined.A service history review was performed, and no non-conformance were detected related to the reported condition.Udi: (b)(4).
|
It was reported from (b)(6) that during service and repair/pre-testing, it was observed that the trigger on the battery oscillator device did not move smoothly.The device also failed pretest for check for sticky trigger.This event did not occur during surgery.There was no patient involvement.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.
|