MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-05 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc..
[14881795]
As reported on (b)(4) 2014, a (b)(6) female patient presented for a lecd thermal ablation of the liver. The patient was placed under anesthesia while the unit was prepped for the procedure. At the start up of the unit, the unit failed the self-test. As there was a delay in the procedure, the patient was under anesthesia for an extended time longer than thirty minutes. The procedure was aborted due to the event. There was no harm or injury to the patient due to the event. It was reported the nanoknife system is available for return for evaluation to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[15476422]
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation. To date the device 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00107 |
| MDR Report Key | 4032073 |
| Report Source | 06 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-07-23 |
| Date of Event | 2014-07-21 |
| Date Mfgr Received | 2014-07-23 |
| Date Added to Maude | 2014-09-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| 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 | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2014-08-05 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-05 |