BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 768012 · Received October 5, 2006

    Report

    Report Number
    2133936-2006-00011
    Event Type
    Other
    Date Received
    October 5, 2006
    Date of Event
    August 26, 2006
    Report Date
    October 5, 2006
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COOLED THERMOCATH (CTC) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, TWO RECTAL THERMOSENSING UNITS (RTU) WERE RETURNED FOR ANALYSIS. WATER BATHS OF BOTH RTUS WERE PERFORMED AND BOTH RTUS READINGS WERE WITHINSPECIFICATION. MANIPULATIONS OF BOTH RTUS WERE ALSO PERFORMED AND NO CHANGES IN THE READINGS OCCURRED. IN ADDITION, SIMULATED TREATMENTS OF BOTH RTUS WERE PERFORMED AND NO ERROR WAS OBSERVED. THE DEVICE HISTORY RECORD FOR THIS CATHETER WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. THE RTU WAS RETURNED; HOWEVER, THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 DAYS AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A RECTAL FISTULA OCCURRED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A TARGIS SYSTEM . FOUR DAYS AFTER, THE PHYSICIAN NOTICED A RECTAL FISTULA HAD OCCURRED. THE PATIENT WAS TREATED WITH A COLOSTOMY AND A SUPRAPUBIC TUBE. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT IS CURRENTLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 060130ML4

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other