MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-03 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM 20400101 manufactured by Angiodynamics.
[17222829]
As reported (b)(6) 2015, a (b)(6) male patient presented for an lecd thermal ablation of the liver. During the procedure, the anesthesiologist noted the patient was in arterial fibrillation (detected by (b)(4)). The anesthesiologist administered medication to the patient to control the a-fib. The medical team continued with the procedure with the patient in that state. After the procedure was successfully completed, the medical team cardioverted the patient back to sinus rhythm. There were no report of problems with the generator or probes. There was no report of permanent harm or injury to the patient due to the event. The reported disposable device is not available for return to the manufacturer for evaluation as it was disposed of by the user.
Patient Sequence No: 1, Text Type: D, B5
[17498566]
This medwatch is not to report a device malfunction, but to report an adverse patient event. It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. A review of the device history records for the disposable probes was performed for any deviations related to the reported event. The review confirms that the lots met all material, assembly, and performance specifications. A review of the service order history for the nanoknife generator (s/n (b)(4)) used during the procedure noted no issues. The unit was successfully installed at the account in (b)(4) 2013. There have been no repairs, servicing and/or upgrades have been made since the unit was installed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2015-00081 |
| MDR Report Key | 4491370 |
| Report Source | 05 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-16 |
| Date of Event | 2015-01-16 |
| Date Mfgr Received | 2015-01-16 |
| Date Added to Maude | 2015-02-09 |
| 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 SINGLE ELECTRODE PROBE, 15CM |
| Generic Name | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2015-02-03 |
| Catalog Number | 20400101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVE. QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-03 |