MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-28 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[24670265]
This report is not to report a device malfunction, but a patient response to the procedure. Based on information provided, the customer reported complaint description of a noisy ecg signal causing a delay in the procedure is confirmed. The system detected the noisy ecg signal and paused energy delivery. Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing or design failure. The nanoknife system functioned as intended. 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. The disposable nanoknife single electrode probe used during the procedure was disposed of by the healthcare facility and is not available to be returned for evaluation. The single use probes could not cause or contribute to a noisy ecg signal. A review of the angiodynamics complaint system noted no trends for this complaint type and product family. This type of complaint will continue to be monitored for trends.
Patient Sequence No: 1, Text Type: N, H10
[24670266]
As reported on (b)(6) 2015, a (b)(6) female patient presented for a nanoknife procedure of lesion in the leg. During the procedure, the user experienced "noise" saturation levels on the sync device monitor. During these periods of noise saturation, the nanoknife generator suspended energy pulse delivery until the situation was resolved. This resulted in an increase in ablation delivery time, in turn prolonging the procedure. The patient was under anesthesia the entire time. It was reported the delay caused no harm or injury to the patient. It was reported the customer declined to return the nanoknife system for assessment, as there was no indication the unit malfunctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2015-00331 |
| MDR Report Key | 5043088 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-28 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-08-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| 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 | 2015-08-28 |
| 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. Hospitalization | 2015-08-28 |