As reported on (b)(4) 2014, a (b)(6) female patient presented for a lecd thermal ablation of the liver.The patient was placed under anesthesia while the unit was prepped for the procedure.At the start up of the unit, the unit failed the self-test.As there was a delay in the procedure, the patient was under anesthesia for an extended time longer than thirty minutes.The procedure was aborted due to the event.There was no harm or injury to the patient due to the event.It was reported the nanoknife system is available for return for evaluation to the manufacturer.
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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.
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