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

Model Number 20300101

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

During self-test, the nanoknife 3.0 generator unit displayed "failed to locate nanoknife controller" error message.The end user had placed the patient under ga prior to turning on the nanoknife generator.Since case was aborted and no treatment provided to patient this event meets the criteria of reportability.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Manufacturer Narrative

The unit was returned to alpha source service center for evaluation.Functional check: performed functional test per svc-002-s10 and failed at step 2.3.6 due to an error stating "failed to locate the nanoknife controller", preventing the self-test from completing and reproducing the customer complaint.Fixed by replacing the control card pcb per svc-002-s17.Repeated functional test and passed.Performed electrical safety test per svc-027 and passed.Unit meets all acceptance criteria.The reported complaint description is confirmed.The unit displayed "failed to locate nanoknife controller" when functional tested.The root cause for the self test failure (failed to locate nanoknife controller) was determined to be caused by a faulty controller card, which was replaced.This is the first reported error for this unit for self-test failure.This is the first time the controller card was replaced.The most likely root cause could be wear and tear.After unit had new hard drive installed, the unit was tested per svc-002-s10 functional test and electrical safety test per svc-027 and met all acceptance criteria.Labeling review: per current user manual (b)(4), rev.A (page 18): section 5: system operation 5.1 procedure overview an overview of a typical nanoknife ablation procedure is listed below.Refer to subsequent sections of this user manual for detail usage instruction on operation of the nanoknife generator.5.1.1 procedure setup (before patient enters procedure room): 1.Plug in the nanoknife generator and cardiac gating device into a grounded power outlet within the procedure room.2.Power on the nanoknife generator.The nanoknife generator will initiate and complete a power-on self-test (post).3.Attach the double pedal footswitch to the nanoknife generator.5.1.2 patient preparation 4.Prepare patient for general anesthesia.5.Position patient into appropriate position for anticipated nanoknife single electrode probe insertion (e.G., supine, prone, lateral, lithotomy).A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Reference (b)(6).

• 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 ; 5086587990
• MDR Report Key: 18615095
• MDR Text Key: 334398930
• Report Number: 1319211-2024-00007
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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