MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-17 for GYNECARE THERMACHOICE III TC003 manufactured by Ethicon.
[2070886]
Per the operative report: "the hysteroscope was gently advanced into the uterine cavity. There were no masses or lesions noted and both ostia were visualized bilaterally. The hysteroscope was removed and the thermachoice device was inserted in the uterine cavity after a standard preparation was done with it. After activation an error message appeared on the machine showing motor alert. The device was turned off and removed from the uterine cavity. After restarting the device, several more attempts were made with the device; however, the balloon kept protruding from the external cervical os and we were unable to use the thermachoice for ablation. The novasure device was then opened and the cervical canal was turned to 3 cm. The device was set at 5 cm and placed in the uterine cavity. The uterine width was felt to be 2. 7 cm after deployment of the device. A cavity assessment was performed. The device was enabled and the burn was completed with the findings noted above. The device was then removed with good char noted on it. "====================== manufacturer response for thermal balloon ablation silicone catheter, gynecare (per site reporter)======================will send return kit. Tracking number (b) (6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2144457 |
| MDR Report Key | 2144457 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-05-10 |
| Date of Event | 2011-05-05 |
| Report Date | 2011-05-10 |
| Date Reported to FDA | 2011-06-17 |
| Date Added to Maude | 2011-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE |
| Generic Name | CATHETER, BALLOON, ABLATION |
| Product Code | MKN |
| Date Received | 2011-06-17 |
| Model Number | THERMACHOICE III |
| Catalog Number | TC003 |
| Lot Number | DAMG18 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Brand Name | THERMACHOICE |
| Generic Name | DEVICE, THERMAL ABLATION |
| Product Code | MNB |
| Date Received | 2011-06-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-17 |