MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-02 for NANOKNIFE SYSTEM 20300101-IVY/AU manufactured by Angiodynamics, Inc.
[131770272]
The nanoknife unit (sn (b)(4)) was assessed and repaired by a field hardware service engineer at the end user's medical facility. A visual "asessment" of the unit noted the unit was in good physical condition. During the functional testing of the unit, the unit could not pass the self-test, indicating one or more of the circuit boards must have failed. The reported complaint description of "unit failed self-test" is confirmed as the unit did not function as intended. The root cause for the self-test failure was determined to be a defective switching board, which was replaced. His is the first reported error of this unit for self-test failure. This is the first time the switching board has been replaced. The most likely root cause of the switching board failure is normal wear and tear. The switching board was replaced and the unit was tested. The unit passed all testing and functioned as intended. The unit passed all acceptance criteria. 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, 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". 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).
Patient Sequence No: 1, Text Type: N, H10
[131770273]
During an ire procedure of the lung, the nanoknife generator shut down. During restart, the self test failed. Several attempts were made to restart the unit, during which time the patient was sedated. The treating physician determined to complete the procedure utilizing a medtronic mwa system. The patient did not have an any injury as a result of the generator failure; however, due to the malfunction, did have a longer than expected anesthetic exposure and an alternate ablative procedure. The customer has requested the facility's unit be evaluated by the manufacturer. The unit has been returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00130 |
| MDR Report Key | 8207834 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM, |
| Product Code | OAB |
| Date Received | 2019-01-02 |
| Returned To Mfg | 2018-12-13 |
| Model Number | 20300101-IVY/AU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |