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

Catalog Number 20300301

Device Problem Computer Software Problem (1112)

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

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

The reported generator 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 device evaluation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics distributor manager reported that the nanoknife 3.0 device experienced an "error 2048" during a patient's pancreas open procedure.The equipment started up correctly, delivering several pulse sequences without problem, but when trying to apply a sequence of additional pulses, after changing the position of the needles, the failure occurred.Various attempts were made to restart the generator, using different power outlets and waiting several minutes with the generator switched off and unplugged, following the manufacturer's instructions.After the first error, the generator did not start working again, giving this error in the different start-up tests.The procedure was not able to be completed as a result of this issue.It was indicated the reported nanoknife generator is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was nanoknife unit, serial number (b)(6).Functional testing of the unit noted the unit did not function as intended.The reported warning message of error 2048 was able to be replicated.To correct this issue,the gome board was replaced.The service testing was performed and the unit passed.The unit also passed the electrical safety test and meets all acceptance criteria.The reported complaint description is confirmed.He unit failed a self test during the initial evaluation.After trying a new fpga and switching board, the gome board was replaced which corrected the error.The root cause for the error 2048 was determined to be a defective gome board which was replaced.This is the first reported error of this unit for error 2048.This is the first time the gome board has been replaced.The most likely root cause of the gome board failure is wear and tear.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, which is supplied to the user with this unit contains the following statements: "the nanoknife generator will begin a start-up self test.It will run through a series of tests before the user gains access to the nanoknife software: initializing device; checking device status; checking connections; testing charge.The user must then click the proceed button, which will shut down the generator, so that it can be restarted.If one of the generator's self-test checks fails, an error message will be displayed.Refer to section 12.3 for a complete list of start-up self test error messages.If all self-tests are successful, the procedure setup screen will appear on the touchscreen lcd display (see figure 6.1.1).If the generator repeatedly fails the self test, 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
• MDR Report Key: 10667690
• MDR Text Key: 213699292
• Report Number: 1319211-2020-00063
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20300301
• Device Lot Number: 03940918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1