Udi: (b)(4).Device evaluation: 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.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
It was reported by (b)(6) that during service and evaluation, it was determined that the bearing of the battery handpiece/modular device seized.It was determined that the device could not disengage the attachment ¿ coupling.It was observed that the device had cosmetic damage and the housing was worn.It was further determined that the device failed pretest for check falling out protection (steal ring), check for roundness, check of free moving, check proper function of the triggers, check the attachment coupling, check for leakage and general condition.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 2019.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
|