MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-03-16 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[70183008]
It was reported that the nanoknife system (sn (b)(4) ) involved in the incident was provided field service. The unit was noted to be in good physical condition. During assessment the generator could not pass the self-test as reported. The switching board was replaced and the unit tested successfully per svc-002-s06 operational verification procedure. The unit meets all acceptance criteria. The customer's reported complaint description was confirmed. During testing the generator did not function as intended, failing the self-test. The root cause for the failure was determined to be a defective switching board. The patient did not suffer any lasting harm or injury due to a prolonged procedure. This was the first time the switching board has been replaced since the unit was delivered to the account in (b)(6) 2016. Unit meets all acceptance criteria. The user manual , which is supplied to the user with this unit contains references to the generator's window display regarding the charge function when in use; "charge section controls the voltage on the capacitors and displays the accumulated energy for ablation. The capacitor status indictor displays the level of the capacitor charge and shows, in volts the voltage present on capacitors. When fully charged, the voltage on capacitors is always greater than the pulse amplitude currently set". The manual also contains warning and caution statements in regards to setting the mains values and replacing the mains use: "do not proceed if the generator does not charge and discharge capacitors correctly when acting on the charge or discharge button. After the discharge button is pressed, the voltage indicated by the high voltage capacitors digital indicator must be lower than 70v". The user manual troubleshooting section also contains a reference as to what to do if experiencing an error message "unable to charge/discharge; " possible reason - the system detected a problem during the charge or discharge of the capacitors. Action to take- : confirm that the stop button is not engaged. If "new probe selection" button is active, click, then return to "pulse generation screen" to reinitialize and start the ablation over. If the "retreat"/ "do not re-treat" buttons are active, click "do not re-treat", do not save, then follow steps above. If the system is not able to recharge or discharge the capacitors, please call angiodynamics customer service". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70183009]
As reported march 03, 2017: there is no report of patient harm or injury. However, as the patient was under anesthesia for greater than a prolonged period of time due to the event, this event meets angiodynamics' criteria pf a reportable event. At the start of the ire procedure, while the patient was under anesthesia, it was reported the nanoknife unit failed the self-test. The unit was rebooted and the procedure was started. Once the procedure had commenced, it was reported the unit had to be rebooted an additional 5 times due to high- current conditions. , the user shut the unit down for a period of 30 minutes, and then rebooted the unit. The procedure was completed with no further malfunctions. It was reported that the patient suffered no adverse effects due to the event. The reported defective device has been returned to the manufacturer for a device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2017-00035 |
| MDR Report Key | 6411473 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-18 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-03-16 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| 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 DEVICE |
| Product Code | OAB |
| Date Received | 2017-03-16 |
| Returned To Mfg | 2017-03-05 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-03-16 |