It was reported that the battery handpiece device had an unspecified malfunction during testing.During in-house engineering evaluation, it was determined that the worked intermittently, the bearings and trigger components were corroded.The device failed pre-tests for check proper function of the triggers, check function of all modes and check response of on/off trigger.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|