As reported on (b)(6) 2014, male patient of unknown age presented for a lecd thermal ablation of the prostate.During the procedure, it was reported the nanoknife unit experienced a hardware communication error message, shutting the unit down.The unit was rebooted, and the procedure was successfully completed using this same unit.However, due to the delay during the procedure, the patient was administered additional anesthesia.It was reported the patient suffered no harm or injury due to the event.It was reported the nanoknife system is available for return for evaluation to the manufacturer.
|
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date, the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The results of the unit evaluation will be sent via a follow up medwatch.
|