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

Model Number 20300101

Device Problem Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

The nanoknife generator (serial number 01851012) is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

During an ire procedure, using the nanoknife system, with the patient under anesthesia, the pedal would not fire when the green "pulse" button was pressed.The clinical specialist tried to reconnect and restart machine and the "arm" pedal worked fine, so it was decided the pedal was the problem.The procedure was completed using another foot pedal, from an account down the road.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.Additional information reported the procedure was delayed for greater than 30 minutes, patient sedated, while attempts to resolve the issue were performed.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).

Manufacturer Narrative

As the reported nanoknife unit was not returned, angiodynamics is unable to perform an evaluation.The reported complaint description could not definitively be confirmed as neither the generator nor foot pedal was returned for service/evaluation.The unit was recently serviced/repaired in the field for not receiving a "pulse" from the foot pedal.It was discovered that the unit had a loose foot pedal connection that was tightened and the unit met acceptance criteria.The customer reported a similar issue during a procedure and determined that the issue appeared to be with the footpedal itself.Hardware service (hws) shipped the customer a new foot pedal to address this issue.Disposable device review: this angiodynamics hardware unit has a related disposable device, however, the reported complaint could not be related to the disposable device.A review of the associated disposable device's lot history records and complaint history is not required.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the user manual states "the system incorporates a double trigger foot pedal system that prevents accidental delivery of procedure pulses.The foot pedals require the user to first arm the system by depressing the "arm" foot pedal, and then sequentially, depressing the "pulse" foot pedal within 10 seconds of arming to deliver energy to the patient." section 8.2 documented problems and solutions states: "malfunction: cannot arm or activate ablation deliver - possible reasons: 1) foot pedal not properly attached to generator - check all foot pedal connections or 2) damaged foot pedal - 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.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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15278728
• MDR Text Key: 305514708
• Report Number: 1319211-2022-00036
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male