MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-26 for GYNECARE THERMACHOICE TC003 * manufactured by Ethicon, Inc..
[3666798]
"thermachoice" machine not functioning, unable to maintain pressure. A second hand piece opened and handed off to the physician. The second hand piece was not functioning. The physician was unable to perform "thermachoice" ablation; however, elected to perform uterine ablation utilizing an alternative uterine ablation. Patient tolerated procedure well. "thermachoice" generator removed from service, tagged, biomed was notified. Hand pieces and packaging saved. Biomed checked generator/hand pieces. Generator given all clear and placed back in service. According to biomed hand pieces one had a pin hole and one seal cracked. What was the original intended procedure? Uterine ablation. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3242464 |
| MDR Report Key | 3242464 |
| Date Received | 2013-04-26 |
| Date of Report | 2013-04-26 |
| Date of Event | 2013-04-16 |
| Report Date | 2013-04-26 |
| Date Reported to FDA | 2013-04-26 |
| Date Reported to Mfgr | 2013-07-23 |
| Date Added to Maude | 2013-07-23 |
| 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 |
| 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 THERMACHOICE |
| Generic Name | DEVICE, THERMAL ABLATION |
| Product Code | MKN |
| Date Received | 2013-04-26 |
| Model Number | TC003 |
| Catalog Number | * |
| Lot Number | DPMG05 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUT 22 WEST SUMMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-26 |