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

Model Number 20300101

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/30/2019

Event Type  Injury  

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.To date, the generator has yet to be returned.Attempts are being made to obtain the unit.The results of the unit evaluation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

A (b)(4), female patient presented for an ire procedure of the pancreas using a nanoknife system.The patient was sedated and 4 nanoknife probes were placed.The unit was booted up and the self-test of the unit initiated.When the unit was performing the foot pedal connectivity test, there was no communication between the two devices.The treating physician attempted to perform trouble shooting on the system, but was unsuccessful.It was reported that the attempt to fix the issue took approximately 3 to 4 hours.The patient was reported to be open and sedated during this delay on procedure.The treating physician determined to abort the procedure as no other method of treatment was available.This event meets the criteria fo a reportable event due to extended delay in procedure and no treatment provided (unnecessary sedation) the facility's unit will be returned in order to be evaluated by the manufacturer.

Manufacturer Narrative

The nanoknife system (serial number 00130508) was returned for assessment.The unit arrived in good physical condition, with 2x power cord, and associated accusync (serial number (b)(4).Functional testing was performed on the unit.The reported complaint description of "generator charged, not possible to arm+ pulse (start the procedure), using foot pedal doesn´t force any action of the generator" could not be duplicated.The associated footswitch was not returned with the unit, therefore testing of the unit with the related footswitch was unable to be performed.Unit meets all acceptance criteria.The reported issue was not confirmed.During functional testing unit functioned as intended.A root cause for the repored event cannot be determined.A review of the device history records (service order system) was performed for the reported serial number (b)(4) 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.The user manual provided with this unit, states: "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", and "troubleshooting: message: error fpga recognition self-test failed.Check that the red stop button is depressed and reboot the system.Possible reasons: red stop button is depressed.Actions: check the red stop button status indicator (green light).It should be lit.If not, twist the button clockwise slightly and release the button.The red stop button indicator should be on." 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 # (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8575005
• MDR Text Key: 143880921
• Report Number: 1319211-2019-00042
• 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: 06/28/2019

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: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR