MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-29 for TARGIS SYSTEM 4000A TC1121A manufactured by Urologix, Inc..
[21668259]
It was reported that after a transurethral microwave treatment procedure, the physician confirmed his patient had developed a rectal fistula. The physician successfully completed the procedure with a targis control unit and a ctc standard microwave treatment catheter on (b)(6)2012. During an office visit with the patient on (b)(6), the physician discovered that the patient had developed a rectal fistula and had urine coming from his rectum.
Patient Sequence No: 1, Text Type: D, B5
[21888218]
No disposable device was returned, therefore, no direct product analysis is available. The treatment file 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 standard procedures and the product met its specification at the time of release. As no device was received for analysis and the treatment file demonstrates the control unit operated appropriately, it is not possible to determine the root cause of the event. This report does not constitute an admission or a conclusion by urologix that the device caused or contributed to the event described in the report nor that the device malfunctioned in any way. No disposable devices were returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00009 |
| MDR Report Key | 2850194 |
| Report Source | 05 |
| Date Received | 2012-11-29 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-11-02 |
| Date Mfgr Received | 2012-11-02 |
| Device Manufacturer Date | 2012-05-16 |
| Date Added to Maude | 2012-11-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVE N |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7634048139 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM FOR BPH |
| Product Code | MEQ |
| Date Received | 2012-11-29 |
| Model Number | 4000A |
| Catalog Number | TC1121A |
| Lot Number | 120515MCA1 |
| Device Expiration Date | 2014-04-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-29 |