BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1048004 · Received May 21, 2008

    Report

    Report Number
    2133936-2006-00006
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    February 10, 2006
    Manufacturer
    UROLOGIX
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER WAS CALLED AND THE CONVERSATION CONCLUDED THAT THE EVENT HAD PREVIOUSLY BEEN REPORTED BY UROLOGOX UNDER REPORT NUMBER 2133936-2006-00006. REPORTER WAS NEW AT THE CLINIC, REVIEWED THE FILES, SAW THE EVENT AND COULD NOT DETERMINE IF IT HAD BEEN PREVIOUSLY REPORTED, SO SHE REPORTED IT. UROLOGIX CONFIRMED THE PATIENT INFORMTION WITH REPORTER AND DETERMINED IT TO BE PREVIOUSLY REPORTED, AND GAVE REPORTER THE REPORT NUMBER TO INCLUDE IN HER FILE. ACCORDING TO THE REPORT FILED BY THE REPORTER, THE PATIENT CURRENLTY HAS A COLOSTOMY. ACCORDING TO UROLOGIX INITIAL REPORT, THE PATIENT WAS TREATED WITH COLOSTOMY AND SUPRAPUBIC TUBE FOR 60 -90 DAYS TO ALLOW THE FISTUAL TO CLOSE NATURALLY. DEVICE WAS NOT RETURNED

    Additional Manufacturer Narrative · 1

    "No device has been returned, therfore no direct product analysis will be available. The device history record for this serial number was reviewed. All manufactuing and quality assurance testing was carried out in accordance with standard procedures.The device history record for this serial number shows that the product met its sprecifications at the time of release. As no device was recieved for analysis, it is not possible to determine the root cause of the event. It is noted a printout of the treatment did not reveal any inconsistency."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A RECTAL FISTUAL OCCURRED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A TARGIS SYSTEM USING A SHORT CATHETER, 32 DAYS LATER, THE PATIENT HAD A FOLLOW UP VISIT AND THE PHYSICIAN NOTICED A RECTAL FISTUL HAD OCCURRED. THE PATIENT WAS TREATED WITH A COLSTOMY AND SUPRAPUBIC TUBE FOR 60-90 DAYS TO ALLOW THE FISTULA TO CLOSE NATURALLY. THE PATIENT STATUS IS REPORTED AS STABLE.

    Description of Event or Problem · 1

    VOLUNTARY REPORT WAS REPORTED FOR AN EVENT THAT HAPPENED AT A FACILITY. PATIENT SUFFERED A BURN AND PROSTARECTAL FISTULA. UPON CLOSER EXAMINIATION AND A PHONE CONVERSATION WITH REPORTER AT THAT SITE, IT WAS DETERMINED THAT THIS EVENT WAS REPORTED BY UROLOGIX IN 2006 AS MFG REPORT # 2133936-2006-00006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other