BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 261418 · Received February 4, 2000

    Report

    Report Number
    1527736-2000-00296
    Event Type
    Malfunction
    Date Received
    February 4, 2000
    Date of Event
    January 3, 2000
    Report Date
    January 3, 2000
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) LF001 WAS USED DURING AN INTERSTITIAL LASER COAGULATION OF THE PROSTATE PROCEDURE. IT WAS REPORTED THAT A DIFFUSER FAULT OCCURRED WHILE TREATING THE LATERAL LOBE. THIS FAULT OCCURRED AFTER ONE MINUTE HAD ELAPSED IN THE TREATMENT. THERE WAS NO APPARENT CAUSE SUCH AS MOVEMENT OF THE SCOPE OR THE PT WHICH MIGHT HAVE STRESSED THE FIBER. WHEN THE SURGEON REMOVED THE FIBER TO INSPECT IT, THE DIFFUSER SECTION LOOKED AS THOUGH IT WAS SEVERED WHERE THE FIRST BLACK MARKER SHOULD HAVE BEEN AND THE SHRINK WRAP WITH THAT MARKER WAS WAY DOWN BY THE TIP OF THE FIBER. THE FIBER LOOKED AS THOUGH IT WAS SLIGHTLY CHARRED AT THE POINT OF BREAKAGE. THE REP FELT THE AREA AND THE DIFFUSER SECTION SEPARATED FROM THE FIBER WITH VERY LITTLE FORCE. THE CASE WAS COMPLETED WITH A NEW FIBER FROM A DIFFERENT LOT NUMBER WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER INDIGO-FIBER GEX INDIGO MEDICAL, INC. NA M4FH2P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other