As reported on (b)(6) 2014, patient of unknown gender and age presented for a lecd thermal ablation of the kidney.While prepping for the procedure, it was reported the nanoknife unit failed its self-test.The procedure was not completed due to this event.Due to the delay during the procedure, the patient was anesthetized for greater than 30 minutes.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.
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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.(b)(4).
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