It was reported from (b)(6) that the electric pen drive device started as soon as the cable was connected.During service and evaluation, it was observed that the control unit was not functioning, defective, the handpiece had a corroded controller and worn out motor.It was also noted that the device failed pre-test for function with foot pedal and test hand switch.It was not reported if the device was used in surgery, or if there was patient involvement reported.It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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