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

Model Number 20300101

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

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife unit (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 device.An investigation into the root cause for event is currently in progress.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported on (b)(6) 2015, during a kidney ire (irreversible electroporation) clinical trial for a pig, the unit failed the self-test start up multiple times.As there was a delay in the procedure, the pig was assumed to be under anesthesia for an extended time.The procedure was aborted due to the event.There was no report of harm or injury to the pig due to the event.It was reported the nanoknife system is available for return evaluation to the manufacturer.

Manufacturer Narrative

The reported nanoknife generator was not returned for assessment and repair.As it was not returned, angiodynamics was unable to perform an evaluation and definitively determine a root cause for the reported complaint description.The reported complaint description of self-test failure could not be confirmed.A review of the hardware service records for the complainant's ire generator (serial number (b)(4)) noted no issues.The user manual , which is supplied to the user with this unit contains the following statements: "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".Disposable device review: this angiodynamics hardware unit has a related disposable device however the reported complaint could not be related to the disposable device.The nanoknife completes the self-test before it allows the unit to engage with the probe or continue to the next step to start treatment.A review of the associated disposable device's lot history records and complaint history is not required.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 reference (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5366339
• MDR Text Key: 36040902
• Report Number: 1319211-2016-00007
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• 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