MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-02 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc.
[125965248]
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).
Patient Sequence No: 1, Text Type: N, H10
[125965249]
As reported to angiodynamics on october 10 2018: the treating physician placed 4 nanoknife probes percutaneously under ct guidance. The distances were entered into the nanoknife software, and suddenly the red stop button with the message "hardware communication failure" displayed. The red stop button was checked and was not depressed. Once the system was rebooted, it failed the first self-test. Multiple reboots were attempted with the same result. Angiodynamics' hardware services was contacted and the issue could not be resolved. The medical facility borrowed a nanoknife generator from the university of arkansas medical center to complete the case. The case was delayed almost 2 hours while another nk generator was brought to baptist medical center. Baptist's biomedical department checked and cleared the new generator to be used prior to its use on the patient. There were no further issues and the case was completed. The patient is doing well. As the patient was under anesthesia during the delay of almost two hours, there was potential for patient risk. As a precaution, the customer has requested the facility's unit be evaluated by the manufacturer. The unit has yet to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00108 |
| MDR Report Key | 8033238 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-11-02 |
| 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 | 2018-11-02 |
| Returned To Mfg | 2018-10-17 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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. Required No Informationntervention | 2018-11-02 |