MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-06 for THERMACHOICE III TC003 * manufactured by Ethicon, Inc..
[5165573]
While attempting to do a balloon ablation the first two balloons would not hold pressure. Since they were the same lot number we tried a 3rd balloon from a different lot that held the pressure. We started the heating cycle, at 3 minutes the machine stated overheated and turned itself off. We had been having some problems with the uterus clamping down (pt problem not equipment or supply) so we started again and at about 3 minutes the machine again turned itself off saying overheating even though the temp monitor stated the temp had actually dropped a bit. Since i have previously spoken with the company who stated four minutes of time was usually good, we tried one more time and got 2 more minutes and discontinued the therapy. The balloon had char on it which is the norm for when the therapy works. First two balloons and machine pulled out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4416175 |
| MDR Report Key | 4416175 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-11-12 |
| Report Date | 2014-11-20 |
| Date Reported to FDA | 2015-01-06 |
| Date Reported to Mfgr | 2015-01-14 |
| Date Added to Maude | 2015-01-14 |
| 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 | 3 |
| 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 | THERMACHOICE III |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2015-01-06 |
| Returned To Mfg | 2014-12-17 |
| Model Number | TC003 |
| Catalog Number | * |
| Lot Number | GPMG101 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST P.O. BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-06 |