MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-23 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[5099497]
A male pt of unknown age presented for a lecd thermal ablation of the prostate on (b)(6)2014. The procedure was successfully completed with no reports of patient complications or device malfunctions. Within a few days post procedure, the pt reported marks to his lower legs (knees) and blistering appeared approx. Two weeks post procedure. By the time the pt made the treating physician that the probe and device cables were not placed near the lower legs during the procedure. The device cables did not exhibit any damage to the cable insulation. There is no report of permanent harm or injury to the patient due to this event. No further intervention has been taken to address the blistering. The symptoms have been self-limiting and are resolving. The disposable device used for the procedure is not available for return to the manufacturer for evaluation as it was disposed of by the end user. The nanoknife generator has been retained by the user as it functioned as intended and there is no report of malfunction.
Patient Sequence No: 1, Text Type: D, B5
[12414312]
The reported nanoknife unit (sn (b)(4)) has been retained by the account and will not be returned to the manufacturer for evaluation, as there is no report of malfunction, but a report of a patient issue. An investigation into the root cause of this incident is currently in progress. The results of the investigation and any follow up information 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. No complications were noted during the operation in either the medical notes or the operation note. The probes are placed in the perineum, the legs are in stirrups with the patient in the lithotomy position. The probe cables came down underneath the patient's legs and away. They are not placed over the top or across the legs of the patients. They did not come into contact with the patient. No further investigation has been taken to address the blistering. The symptoms have been self-limiting and are resolving. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00124 |
| MDR Report Key | 4173241 |
| Report Source | 06 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-08-26 |
| Date of Event | 2014-07-27 |
| Date Mfgr Received | 2014-08-26 |
| Date Added to Maude | 2014-10-16 |
| 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 | 2014-09-23 |
| Model Number | 20300101 |
| 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 | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-23 |