It was reported to richard wolf: "(b)(6) called (b)(6), the local rep, during the procedure.
When the footswitch for the power drive art1 was activated, the controller displayed a "foot pedal defective" error message.
The rep asked them to disconnect and re-connect the footswitch, and the message was no longer displayed.
When they started the procedure, the handpiece wasn't rotating the burr.
They disconnected the cable from the handpiece and generator, and re-connected.
The handpiece still would not rotate the burr.
Then the rep called me to conference with the operating room, and that's when the physician stopped the case.
He had made an incision, stopped the case, closed the incision, and will re-schedule.
(b)(6), the local sales rep went to the account and determined that the (2) 89955.
0000 m4 motor handpieces and the 8564.
851 connecting cable were functioning properly, and will not be returned to us for evaluation.
" will the device be returned? yes.
Was the device being used on a patient when the reporting issue occurred? yes.
Was there any injury or illness to the patient due to the reported issue? no.
Was there any injury or illness to any other personnel due to the reported issue? no.
Did the issue cause a delay in the procedure being performed? yes.
Did the delay put the patient at risk? yes.
Was there a similar back-up device available for use? no.
Was the scheduled procedure completed? yes.
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