BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1033245 · Received April 25, 2008

    Report

    Report Number
    2133936-2008-00003
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 24, 2008
    Manufacturer
    UROLOGIX
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN RTU PLUS HANDLE WAS RETURNED ALONG WITH THE TARGIS CONTROL UNIT FOR EVALUATION. DEVICE ANALYSIS DID NOT REVEAL A PRODUCT DEFECT AS THE DEVICES FUNCTIONED PROPERLY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS DEVICE SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. IN THE PHYSICIAN'S MEDICAL OPINION, DUE TO THE NATURE OF THE PATIENTS DIVERTICULITIS, IT IS UNLIKELY THE DEVICE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 7 WEEKS AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE PHYSICIAN SUSPECTED A URETHRAL/RECTAL FISTULA HAD OCCURRED. ABOUT 3 WEEKS LATER, THE PHYSICIAN WAS FINALLY ABLE TO PERFORM CYSTOSCOPY AT WHICH TIME HE CHANGED THE DIAGNOSIS FROM A URETHRAL-RECTAL FISTULA TO A COLOVESICAL FISTULA RESULTING FROM DIVERTICULITIS DISEASE. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A TARGIS CONTROL UNIT AND A CTC MICROWAVE TREATMENT CATHETER. THE PROCEDURE WAS STRAIGHTFORWARD AND UNEVENTFUL. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT?S COLORECTAL SURGEON IS ADDRESSING HIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX 4000A 070625MC3*

    Patients

    Seq Age Sex Outcome Treatment
    1 Other