MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-22 for THERMACHOICE III TC003 H205TC0031 manufactured by Ethicon, Inc..
[2024130]
A thermal disposable kit was opened and connected to machine. The writing in window on machine stated handpiece error 5003. The machine was shut off and turned back on. It continued to state error. The machine was again shut off, the disposables disconnected and reapplied. The machine was turned back on but it continued to read error. A new thermal kit was opened and connected to machine without problems. It is not known if new kit was same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2082173 |
| MDR Report Key | 2082173 |
| Date Received | 2011-04-22 |
| Date of Report | 2011-04-22 |
| Date of Event | 2011-03-23 |
| Report Date | 2011-04-22 |
| Date Reported to FDA | 2011-04-22 |
| Date Added to Maude | 2011-05-09 |
| 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 | THERMACHOICE III |
| Generic Name | UTERINE ABLATION DEVICE |
| Product Code | MKN |
| Date Received | 2011-04-22 |
| Returned To Mfg | 2011-04-22 |
| Model Number | TC003 |
| Catalog Number | H205TC0031 |
| Lot Number | CJMG04 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-22 |