MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-08 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[25615419]
As there was no report of a device malfunction, the customer has determined not to return the unit to the manufacturer for assessment at this time. 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 was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint. The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[25615420]
As reported on (b)(6) 2015, a male patient of unknown age presented for a nanoknife procedure. During the procedure the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors. It was reported that during the procedure, the patient experienced arrhythmia. The arrhythmia was successfully treated and procedure was successfully completed. It was reported the patient was stable, post procedure. The customer has determined not to return the nanoknife system for evaluation to the manufacturer for assessment as there was no report of malfunction of the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2015-00335 |
| MDR Report Key | 5070413 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-09-11 |
| 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 | DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| 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 | 0 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2015-09-08 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2015-09-08 |