BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 788044 · Received November 22, 2006

    Report

    Report Number
    2133936-2006-00014
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    August 14, 2006
    Report Date
    November 22, 2006
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED, THEREFORE NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE DEVICE HISTORY RECORD FOR THIS SERIAL # WAS REVIEWED. 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. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 WEEKS AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A RECTAL FISTULA OCCURRED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A TARGIS SYSTEM. TWO WEEKS AFTER, THE PHYSICIAN NOTICED A RECTAL FISTULA HAD OCCURRED. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. MULTIPLE ATTEMPTS TO GATHER FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 060630M1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other