MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-04-06 for TARGIS SYSTEM TC1121C 4000 manufactured by Urologix, Inc..
[2603826]
It is reported approximately 2 minutes into a transurethral microwave treatment (tumt) procedure, the pt? S rectal temperatures began to elevate, the pt began to feel faint and his color was very pale. The physician stopped the treatment and administered oxygen to the pt and subsequently had the pt transported to the emergency room. The pt was not admitted to the hospital, there were no further pt injuries and the pt is currently doing fine. The physician suspects the pt had a vasovagal reaction.
Patient Sequence No: 1, Text Type: D, B5
[9947980]
No disposable devices will be returned; therefore no direct product analysis is available. The treatment file printout from the control unit was obtained and reviewed along with the catheter device history record. All manufacturing and quality assurance testing was carried out in accordance with the standard procedures and the product met its specifications at the time of release. The treatment file revealed that the system and catheter operated properly and that the treatment was interrupted by the operator at the time of the event. The physician suspected that the pt experienced a vasovagal response. The pt has recovered and is currently doing fine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00001 |
| MDR Report Key | 2529538 |
| Report Source | 06,07 |
| Date Received | 2012-04-06 |
| Date of Report | 2012-04-05 |
| Date of Event | 2012-03-05 |
| Date Mfgr Received | 2012-03-05 |
| Device Manufacturer Date | 2012-02-06 |
| Date Added to Maude | 2012-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. GAYLE COOPER |
| Manufacturer Street | 14405 21ST AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7634751400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM, PRODUCT CODE |
| Product Code | MEQ |
| Date Received | 2012-04-06 |
| Model Number | TC1121C |
| Catalog Number | 4000 |
| Lot Number | 120203MCA1 |
| ID Number | CU: 292175 |
| Device Expiration Date | 2014-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC. |
| Manufacturer Address | 14405 21ST AVE. NORTH MINNEAPOLIS MN 55447200 US 55447 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-06 |