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 2014-05-27 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[4591632]
As reported on (b)(6) 2014, pt of unk gender and age presented for a lecd thermal ablation. During the procedure, it was reported the nanoknife unit experienced a hardware communication error message, shutting the unit down. The unit was rebooted several times, and the procedure was successfully completed using this same unit. However due to the extended delay during the procedure, the pt was administered additional medication. It was reported the pt suffered no harm or injury due to the event. It was reported the nanoknife system is available for return for evaluation to the mfr.
Patient Sequence No: 1, Text Type: D, B5
[12017865]
It was reported that the device involved in the incident is available to be returned to the mfr for evaluation. To date, the device has yet to 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66370945]
The ire generator (serial number (b)(4)) received field service by an angiodynamics' field service engineer. No defects of the generator were noted during initial assessment. Functional assessment was performed on the unit. The unit met all acceptance criteria. There was no report of harm or injury to the patient due to the procedure being prolonged. The reported complaint description could not be confirmed as the unit functioned as intended during testing and no errors were found in the log files. A root cause for the complaint description could not be determined as no defects were found with the generator. 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, provided to the user with the system instructs the user on how to troubleshoot when the generator fails self-testing as well as unit shut down issues. The catalog and lot number of the disposable probe used during the event was not reported by the user. 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 | 1319211-2014-00069 |
| MDR Report Key | 3881761 |
| Report Source | 06,USER FACILITY |
| Date Received | 2014-05-27 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-05-09 |
| Date Mfgr Received | 2014-05-09 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2014-07-02 |
| 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 |
| 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 | 2014-05-27 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-27 |