MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-05 for GYNECARE THERMACHOICE III * TC003 manufactured by Ethicon, Inc..
[3741556]
During procedure, a thermachoice manipulator was given to scrub tech and was attached to the corresponding thermachoice unit. It was set up according to instructions. Thermachoice unit turned on fine but manipulator did not work or turn on. A new thermachoice manipulator was opened and worked fine with no problems. No injury to anyone. Malfunctioning manipulator was returned to team leader to keep track of failed equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3359356 |
| MDR Report Key | 3359356 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-09-05 |
| Date of Event | 2013-08-30 |
| Report Date | 2013-09-05 |
| Date Reported to FDA | 2013-09-05 |
| Date Reported to Mfgr | 2013-09-20 |
| Date Added to Maude | 2013-09-20 |
| 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 III |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2013-09-05 |
| Returned To Mfg | 2013-09-04 |
| Model Number | * |
| Catalog Number | TC003 |
| Lot Number | EKMG09 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 45242 US 45242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-05 |