MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number H787203003010

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife system (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation.The results of the unit evaluation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

A doctor reported that, during an ire procedure, nanoknife generator (serial number (b)(4)) gave several error messages after needles were placed in the patient and connected.The unit would not charge for the conductivity test and had to be rebooted 4 times.The last reboot was done, after dumping the charge, by pressing the red button on and off; that seemed to have resolved the issue.The procedure was completed.There was no patient harm or adverse event reported by the end user.The patient was reported to have been under anesthesia for a prolonged period greater than 30 minuted due to the event.This poses a patient safety risk, therefore the event meets the criteria as a reportable adverse event.As a precaution, the customer has requested the facility's unit be evaluated by the manufacturer.The unit has yet to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was nanoknife unit serial number (b)(6).During functional testing the unit performed as intended.No issues were noted.The reported complaint description is not confirmed.The unit functioned as intended during functional testing at task.Log files were extracted from the unit and sent to angiodynamics r&d to review.R&d observed unusual error; "error 2020:-04-16 11:31:13.00-nkcontrollerl sethazardflags (2)" and recommended to replace the charge board and the power supply as a precaution.The root cause for the error message was unable to be definitively determined but the charge board and power supply were replaced as a precaution.This is the first reported error of this unit for this error message.This is the first time the charge board and power supply has been replaced.The unit was tested with the new charge board and power supply functional test and met all acceptance criteria.A review of the device history records (service order system) was performed for the reported serial number (b)(6) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.Labeling review: the user manual (nanknife user manual, which is supplied to the user with this unit contains the following statements: "2.2 safety features of the generator the generator incorporates the following safety features to assist the user in delivering a safe application: conductivity test: after electrode probes are placed and prior to pulse delivery, the generator sends one low-energy pulse between each active probe pair through the targeted ablation area to confirm the tissue impedance is within an acceptable range." and "8.7.1 how to start the conductivity test the conductivity test involves delivering one low-energy pulse between each active probe pair through the targeted ablation area to confirm the tissue impedance is within an acceptable range.The conductivity test voltage is approximately 400 volts.Delivery of the conductivity test is started using the double pedal footswitch." and "malfunction: cannot arm or activate conductivity test or pulse delivery.Possible reasons 1) double pedal footswitch not properly attached to generator.Action: check double pedal footswitch cable connections; 2) the 10 second countdown between pressing the left (arm) footswitch pedal and the right (pulse) footswitch pedal has expired.Action: press the left (arm) footswitch pedal again to re-arm the nanoknife generator.Then press the right (pulse) footswitch pedal within 10 seconds to start pulse delivery; 3) double pedal footswtich is defective.Action: call angiodynamics hardware service." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10048585
• MDR Text Key: 190676448
• Report Number: 1319211-2020-00032
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H787203003010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other