MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-12 for NW ABLATION SYSTEM, US NWC1US1N manufactured by Neuwave Medical, Inc..
[187166888]
(b)(4). Batch # unk. We did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check manufacturing records for any related non-conformance. Additional information was requested, and the following was obtained: what were the indications for the ablation? Unknown about the indications for ablation. What was the location of probe to damaged ureter? 1. 1 cm from the ureter. What kind of damage was observed to ureter? Unknown. Did the patient require any type of treatment? If so, please explain. Unknown. Were any difficulties experienced during the ablation? No difficulties experienced during the ablation. How long after ablation was scan performed? Unknown. What is the surgeon? S opinion of cause of damage to ureter? The physician did not know the why the damage happened.
Patient Sequence No: 1, Text Type: N, H10
[187166889]
It was reported that during a follow up scan the ureter had damage post scan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2020-00004 |
| MDR Report Key | 9824931 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal | 53704 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | NEUWAVE MEDICAL, INC. |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NW ABLATION SYSTEM, US |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-03-12 |
| Model Number | NWC1US1N |
| Catalog Number | NWC1US1N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUWAVE MEDICAL, INC. |
| Manufacturer Address | 3529 ANDERSON ST MADISON 53704 US 53704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |