MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-05 for GYNECARE THERMACHOICE III manufactured by Ethicon,.
[1883956]
Md scheduled procedure as a thermal balloon ablation -- intrauterine. Device did not keep pressure according to parameters of the thermal balloon to establish a proper start of ablating. Another device was opened with the same issue. The charge nurse was then called to operating room to assist troubleshooting with the surgeon. A third device was then opened and used without incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020163 |
| MDR Report Key | 2045874 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-03-24 |
| Date of Event | 2011-03-10 |
| Date Added to Maude | 2011-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE THERMACHOICE III |
| Generic Name | UTERINE BALLOON THERAPY SYSTEM |
| Product Code | MKN |
| Date Received | 2011-04-05 |
| Lot Number | CKMG12 |
| Device Expiration Date | 2012-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, |
| Manufacturer Address | RTE. 22 W. SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-05 |