MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-10 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[51812244]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[51812245]
As reported july 15, 2016, a patient of unknown age and gender presented for an ire (irreversible electroporation) procedure of the liver. During the procedure, the nanoknife system displayed a communication error however, continued to deliver pulses. The unit was immediately turned off by the treating physician. The unit was rebooted and the treating physician determined to resume the procedure. During the remaining procedure, the patient experienced ventricular tachycardia/ventricular fibrillation for about one minute. Defibrillation was successfully performed on the patient and again, the physician resumed the procedure. It was reported the patient remained stable for the remainder of the procedure. It was reported the nanoknife system is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2016-00112 |
| MDR Report Key | 5866390 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-10 |
| Date of Report | 2017-08-31 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2016-07-15 |
| Date Added to Maude | 2016-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 | 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 | 2016-08-10 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2016-08-10 |