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 2019-05-02 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc.
[143880921]
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. The results of the unit evaluation will be sent via a follow up medwatch. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143880922]
A (b)(4), female patient presented for an ire procedure of the pancreas using a nanoknife system. The patient was sedated and 4 nanoknife probes were placed. The unit was booted up and the self-test of the unit initiated. When the unit was performing the foot pedal connectivity test, there was no communication between the two devices. The treating physician attempted to perform trouble shooting on the system, but was unsuccessful. It was reported that the attempt to fix the issue took approximately 3 to 4 hours. The patient was reported to be open and sedated during this delay on procedure. The treating physician determined to abort the procedure as no other method of treatment was available. This event meets the criteria fo a reportable event due to extended delay in procedure and no treatment provided (unnecessary sedation) the facility's unit will be returned in order to be evaluated by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2019-00042 |
| MDR Report Key | 8575005 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-02 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| 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 | 2019-05-02 |
| Returned To Mfg | 2019-05-15 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |