BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1644654 · Received March 30, 2010

    Report

    Report Number
    2133936-2010-00006
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 26, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS WAS CONDUCTED. THE TREATMENT FILE FROM THE CONTROL UNIT WAS OBTAINED AND ANALYZED BY ENGINEERING. RESULTS OF THE ANALYSIS CONFIRM THAT THE CONTROL UNIT OPERATED PROPERLY. THE CATHETER AND (B) (4) DEVICE HISTORY RECORDS WERE REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES AND THE DEVICES MET SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS RETURNED FOR ANALYSIS AND THE TREATMENT FILE DEMONSTRATES THE CONTROL UNIT OPERATED APPROPRIATELY, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT (TUMT) PROCEDURE, THE PHYSICIAN CONFIRMED HIS PT HAD DEVELOPED A RECTAL FISTULA. THE PHYSICIAN SUCCESSFULLY COMPLETED THE TUMT PROCEDURE WITH A UROLOGIX TARGIS CONTROL UNIT AND TARGIS SHORT (2.5-3.5 CM) MICROWAVE TREATMENT CATHETER. APPROXIMATELY 6 WEEKS AFTER THE TREATMENT, THE PHYSICIAN DIAGNOSED THE PT WITH A FISTULA AND HE WAS IMMEDIATELY TREATED WITH A COLOSTOMY. NO FURTHER INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 090930MG1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other