MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-26 for THERMACHOICE BALLOON ABLATION WAND manufactured by Gynecare.
[3921491]
Thermachoice balloon ablation wand did not reach appropriate pressure to allow the heating mechanism to begin. Wand removed and noted 5cc's of fluid in the proximal end of wand was missing. Happened a second time with a new wand-not reaching appropriate pressure to allow the heating to begin. In another case, the machine was showing an error code. A backup machine was used to finish the case. Product: gynecare thermachoice balloon ablation wand, malfunctioned on two different cases-(b)(6)2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032052 |
| MDR Report Key | 3379120 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-07-17 |
| Date Added to Maude | 2013-10-02 |
| 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 | 0 |
| Health Professional | 0 |
| 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 | THERMACHOICE BALLOON ABLATION WAND |
| Generic Name | THERMACHOICE ABLATION |
| Product Code | MKN |
| Date Received | 2013-09-26 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYNECARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-26 |