MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2014-11-19 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc..
[17689144]
As reported on (b)(6) 2014, a patient of unknown age and gender presented for a lecd thermal ablation of the pancreas. The patient was placed under anesthesia while the unit was prepped for the procedure. At the start up of the unit, the unit failed the self-test. As there was a delay in the procedure, the patient was under anesthesia for an extended time. A second nanoknife unit, available at the medical facility, was utilized to successfully complete the procedure. There was no harm or injury to the patient due to the event. It was reported the nanoknife system is available for return for evaluation to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[17789695]
It was reported that the nanoknife unit (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation. To date the generator has yet ot be returned. Attempts are being made to obtain the device. An investigation into the root cause for event is currently in progress. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. The results of the unit evaluation will be sent via a follow up medwatch.
Patient Sequence No: 1, Text Type: N, H10
[68481476]
Nanoknife unit (sn (b)(4)) was returned for evaluation and repair. During assessment of the returned generator, the unit failed the self-test. Further investigation found that the switching board was defective and that the stop button was inoperable. The reported complaint description was confirmed as the unit did not function as intended. The root cause for the complaint description was determined to be a defective switching board. The switching board was replaced and the stop button was refitted to operate as intended. The generator was tested per operational verification procedure and met all acceptance criteria. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. The user manual (nanoknife user manual, which is supplied to the user with this unit contains information referencing self-testing and troubleshooting protocols for self test failures. This angiodynamics hardware unit has a related disposable device however the reported complaint could not be related to the disposable device. The nanoknife completes the self-test before it allows the unit to engage with the probe or continue to the next step to start treatment. As reported, there was no harm to the patient due to the delay in procedure. The case was completed with another nanoknife unit without further complications. 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
| Report Number | 1319211-2014-00200 |
| MDR Report Key | 4289198 |
| Report Source | 06,USER FACILITY |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-12-04 |
| 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 | DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| 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 | 2014-11-19 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |