MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-29 for NEUWAVE PR XT PROBE 15CM 15GA PR15XT manufactured by Neuwave Medical, Inc..
[166540800]
(b)(4). The lot was not provided; therefore, a manufacturing record evaluation could not be performed. Additional information was requested and the following was obtained: what were the indications for the ablation procedure? - soft tissue ablation. What was the size of the lesion? - unknown. At what depth was the probe tip located? - unknown. Where was the tip of the trocar in relation to the probe tip? - unknown. Were any error messages displayed or device issues identified? Please describe. - the tissue-loc thermocouple on channels 1 and 3 has failed. When was the burn identified? After the procedure. What was the degree of the skin burn? Unknown. Did the patient receive treatment for the skin burn? If yes, please describe. Yes- debriding. Are photos of the burn or any imaging available? No. What is the current status of the patient? Unknown.
Patient Sequence No: 1, Text Type: N, H10
[166540801]
It was reported that during a liver ablation: "i was not present for the event, but was relayed the following information. A patient sustained injury during a microwave ablation procedure. Patient sustained burn on umbilicus. The probe used was a pr15xt and was utilized in conjunction with a metal trocar. " it is unknown how the case was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2019-00047 |
| MDR Report Key | 9249816 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2019-10-29 |
| 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 | NEUWAVE PR XT PROBE 15CM 15GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-10-29 |
| Catalog Number | PR15XT |
| Lot Number | ML19024082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-10-29 |