MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-13 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[42525521]
It was reported that the user has declined to return the nanoknife system (sn (b)(4)) involved in the incident to the manufacturer for assessment and repair at this time. Attempts are being made by angiodynamics to obtain additional information in regards to the event. An investigation into the root cause for the event is currently in process. A review of the service history 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. Complaint # (b)(4). Device is not available for return
Patient Sequence No: 1, Text Type: N, H10
[42525522]
As reported (b)(6) 2016, a patient of unknown age and gender presented for an ire (irreversible electroporation) procedure. It was reported that during the procedure, the nanoknife system shut down multiple times. The unit was restarted and the procedure was resumed each time. There was no report of harm or injury to the patient due to the event. As there was a delay in the procedure, the patient was assumed to be under anesthesia for an extended period of time. It was reported the customer declined to return the nanoknife system for assessment and repair at this time.
Patient Sequence No: 1, Text Type: D, B5
[64450527]
The nanoknife generator (sn (b)(4)) was returned for evaluation and repair. The unit returned with a damaged front wheel. No additional damage was noted. The unit was tested per the operational verification procedure and at additional settings to determine if reported error could be duplicated. The reported error could not be duplicated, however, the error log had a recorded failure of the fpga board during the previous use that would suggest the unit had shut down during use. Although the reported fault could not be duplicated during functional testing, the complaint is confirmed based on a review of the unit's error logs. Based on the error logs, the root cause for the unit shutting down was a failure of the fpga board. This was the first repair since the unit was delivered to the account in (b)(6) 2014. The most likely root cause for the fpga board is wear and tear. The fpga board was replaced, and the damaged wheel was realigned. The user manual (nanoknife user manual, 160-105261 rev 01 version 2. 2. 1), instructs the user to reboot the system to let the auto-test check the system. Repeat any portions of ablation that were not delivered. A review of the angiodynamics complaint system noted no trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2016-00056 |
| MDR Report Key | 5573404 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-13 |
| Date of Report | 2016-03-21 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-04-13 |
| 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 | MR. LAW RYAN |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| 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 DEVICE |
| Product Code | OAB |
| Date Received | 2016-04-13 |
| Returned To Mfg | 2016-04-20 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-13 |