BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 2850194 · Received November 29, 2012

    Report

    Report Number
    2133936-2012-00009
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 21, 2012
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM FOR BPH MEQ UROLOGIX, INC. 4000A 120515MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other