MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-14 for NANOKNIFE SYSTEM 20400104 manufactured by Angiodynamics.
[34912663]
The reported defective device has yet to be returned to the mfr for a device eval. The firm is attempting to obtain the device. An investigation into the root cause for product problem is currently in progress. The results of the device eval will be sent via a f/u medwatch. A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly, and performance specs. A review of the service order history for the nanoknife generator (s/n (b)(4)) used during the procedure noted no issues. The unit was successfully installed at the account in (b)(6) of 2014. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34912664]
As reported on (b)(6) 2015, a (b)(6) y/o female presented for a nanoknife procedure of the pancreas. During the procedure, the insulated sleeve detached from the probe. The pt experienced a darkening of the skin at the insertion site believed to be a possible burn due to the event. The treating physician determined to stop the procedure due to the event. There was no reports of permanent harm or injury to the pt due to the event. Add'l info provided reported the pt was treated with symptomatic treatment of anti-infection and other burn treatments. It was reported the disposable device is available for return to the mfr for eval.
Patient Sequence No: 1, Text Type: D, B5
[47664371]
Received one 15cm ire single electrode probe. The device was forwarded to the angiodynamics' vendor for evaluation. Per the vendor response , "manufacturing records have been reviewed. No issues or changes that would be relevant to the complaint were identified. " the customer's reported complaint description of the insulated sleeve detaching is confirmed. Although the complaint description is confirmed, a definitive root cause cannot be determined. A possible contributing factor could be if the probe was exposed to a sharp object or mishandled during the procedure. A review of the lot history records was performed for lot 140410 for any deviations related to the reported event of the complaint. The review confirmed that the packaging lots and all component lots met all material, assembly, and performance specification. The 15cm single electrode probe ifu states: "warnings: do not use a device with damaged insulation. Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device. Attachments may damage the insulation and contribute to patient injury. " 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2015-00381 |
| MDR Report Key | 5337960 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-14 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-10-16 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-12-31 |
| 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 | MR. DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| 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 | 2015-12-14 |
| Returned To Mfg | 2015-12-03 |
| Catalog Number | 20400104 |
| Lot Number | 140410 |
| Device Expiration Date | 2017-04-01 |
| 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 |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-14 |