MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-04 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM 20400101 manufactured by Angiodynamics.
[4365658]
As reported (b)(6) 2014, a pt of unk age and gender presented for a nanoknife ablation procedure of the pancreas. During the procedure the treating physician noted high voltage registering between two probes. The voltage was adjusted down, and the treatment was initiated. The unit then displayed a high voltage and a mandatory stop message displayed. The treating physician shut down the unit, and exchanged the probes with a new of the same. Treatment was restarted, and the event reoccurred. The procedure was stopped at that time. There was no report of harm or injury to the pt due to this event. It was reported that the disposable device is available for return to the manufacturer for eval.
Patient Sequence No: 1, Text Type: D, B5
[11786961]
The reported defective device has yet to be returned to the manufacturer for a device eval. The firm is attempting to obtain the device. An investigation into the root cause for product problem is currently in progress. The results of the device eval will be sent via a follow up medwatch. A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly, and performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00021 |
| MDR Report Key | 3804612 |
| Report Source | 06 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-07 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-05-29 |
| 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 | 2014-03-04 |
| Catalog Number | 20400101 |
| Lot Number | 131112 |
| Device Expiration Date | 2016-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |