MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-10-21 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[58073424]
It was reported that the nanoknife system (sn (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. An investigation into the root cause for the event is currently in process. The results of the unit evaluation will be sent via a follow up medwatch. (b)(4). Device not returned to date.
Patient Sequence No: 1, Text Type: N, H10
[58073425]
As reported september 29, 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure of the kidney. During the procedure, the nanoknife system unexpectedly shut down approximately 3 times. Each time, the unit was restarted and the procedure was resumed. As there was a delay in the procedure due to the unit malfunction, it is assumed the patient was under anesthesia for an extended time. 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
[66261559]
The nanoknife generator received field service at the customer site for evaluation and repair. The unit was noted to be in good physical condition. A review of the log files confirmed that the generator had failed the self-test, indicating a gome board or switching board failure. The gome board was replaced and the unit tested successfully per the operational verification procedure. The unit meets all acceptance criteria. The customer's reported complaint description was confirmed. A review of the log files found that the generator had failed the self-test. The patient did not suffer any harm or injury due to a prolonged procedure. This was the first time the gome board has been replaced since the unit was delivered to the account in december 2011. The most likely root cause for the defective gome board is normal wear and tear. A review of the hardware service records for the complainant's ire generator (serial number (b)(4)) noted no issues. The user manual, instructs the user to reboot the system to let the auto-test check the system. Repeat any portions of ablation that were not delivered. Disposable device review: this angiodynamics hardware unit has a related disposable device however the reported complaint could not be related to the disposable device. An issue with the single use electrode probes could not cause or contribute to a gome board failing. A review of the associated disposable device's lot history records and complaint history is not required. A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. Complaint reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2016-00144 |
| MDR Report Key | 6046891 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-10-21 |
| Date of Report | 2016-01-25 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2016-09-29 |
| Date Added to Maude | 2016-10-21 |
| 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 | 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 | 2016-10-21 |
| Returned To Mfg | 2016-10-05 |
| 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 | 2016-10-21 |