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 01/24/2024

Event Type  malfunction  

Event Description

While performing a prostate case with a nanoknife generator.When delivering the test pulse, the charge section could not charge up and a warning message (failure to charge up ) came out then hardware communication error.They pressed "ok", and the machine shut down.They could not reboot tbhe unit despite 6 attempts.The unit could not pass the self-test, and the user also tried pressing emergency button a few times.The ot manager decided to abandon the procedure, removed the probe and disposed of it.At that time, they did a seventh attempt to start the unit, which resulted in the unit rebooting and passing the self test.The procedure was resumed with three new probes.The procedure was completed and the patient did not experience any adverse effects, harm, or require medical intervention because of this incident.This event has been assessed as a reportable due to patient safety risk, as the patient was under anesthesia for greater than 30 minutes as considered normal for this procedure.

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The result of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

The unit was evaluated in the field by task field service technician for evaluation.Functional check: unit is in good physical condition.During field service at the hospital, fault cannot be replicated upon multiple restart and self-tests were passed.Gome board was changed preventively because logfiles indicated the failure originated from the gome board failing to discharge.After replacement of gome board, unit passed ov test and electrical safety.The reported complaint description was not confirmed.During field service at the hospital, the unit fault cannot be replicated upon multiple restart and self-tests were passed.The gome board was changed preventively because logfiles indicated the failure originated from the gome board failing to discharge.The root cause for the self-test failure & charge fault was not definitively determined because the issue could not be duplicated, however, it could be caused by a faulty gome board, which was replaced as a precaution.The unit was tested with the new gome board per functional test and electrical safety and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial number 02050313 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.This unit has had no previous complaint related service orders performed.Labeling review: the user manual (nanoknife user manual, 160-105261-21r02 version 2.2.1), which is supplied to the user with this unit states: (charge fault) "the operating system will automatically begin its start-up process and self-checks.It will run through the following self-checks before the user is able to begin the procedure process: initializing device, checking connections, checking status, checking memory, device setup, testing charge, test delivery", "a screen will display each check's progress until the generator completes the start-up self-test and all checks pass successfully", "if one of the generator's self-tests fails, an error message will be displayed.Figure 4.2.3 is an example of an error message.The user must then click ok, which will shut down the generator, so that it can be restarted.If all self-tests are successful, the information screen (see figure 5.1.1) then appears next on the lcd display." (self-test fails) "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.If one of the generator's self-test checks fails, an error message will be displayed.Figure 4.2.3 is an example of an error message.The user must then click the proceed button, which will shut down the generator, so that it can be restarted.The nanoknife generator startup self-test has failed because of a damaged or faulty component.Note the number listed in parenthesis in the title of the popup.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 pr(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 ; 5086587990
• MDR Report Key: 18741579
• MDR Text Key: 335823892
• Report Number: 1319211-2024-00010
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/24/2024
• Supplement Dates FDA Received: 03/26/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male