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.
Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Udi: (b)(4).
Concomitant medical devices and therapy dates, array clamp devices and satellite station device, (b)(6) 2022.
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This is report 1 of 5 for the same event.
It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use.
Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices.
It was reported that there were a total of four array clamps that released the array without pressing the button.
There was patient involvement.
There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully.
All available information has been disclosed.
Multiple attempts have been made to obtain additional information.
No additional information has been received.
If additional information should become available, a supplemental medwatch will be submitted accordingly.
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