MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-10 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[74831520]
It was reported that the nanoknife system ((b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation. To date, the generator has yet to be returned. Attempts are being made to obtain the unit. The results of the unit evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74831521]
As reported to angiodynamics on april 13, 2017. The nanoknife system had already been started up and passed all self checks prior to case. The planning screen was activated and on standby until the physician was ready to use the unit. When the physician proceeded to return to the first screen in order to input the patient data, the screen had completely frozen and was not responding to pressing of the touch screen or scratch pad. An attempt was made to reboot the system, but it then would not pass the final test on the start-up screen. This procedure was repeated about 8 times but the same issue occurred. The patient had been anesthetized and 3x nanknife probes had already been inserted into the patient. The patient was reported to have been under anaesthesia for a prolonged period greater than 30 minuted due to the event. It was reported that the patient suffered no adverse effects due to the event. It was reported the nanoknife system is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2017-00053 |
| MDR Report Key | 6556528 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-10 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-13 |
| Date Added to Maude | 2017-05-10 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187924112 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| 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 | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2017-05-10 |
| Returned To Mfg | 2017-04-25 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-10 |