BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO PROSTATE LASER

    MDR report key: 201487 · Received December 11, 1998

    Report

    Report Number
    201487
    Event Type
    Malfunction
    Date Received
    December 11, 1998
    Date of Event
    December 2, 1998
    Report Date
    December 8, 1998
    Manufacturer
    INDIGO MEDICAL INC
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR NON-COAGULATION PROSTATE LASER. WHEN DR BEGAN PROCEDURE AFTER INSERTING THE FIBER IN THE PROPER POSITION, THE LASER SCREEN CONTINUED TO DISPLAY ERROR MESSAGE "BLACK BODY". USED LASER MANUAL FOR TROUBLESHOOTING AND PERFORMED THE REQUIRED STEPS TO CORRECT THE CONDITION TO NO AVAIL. TELEPHONE CALL PLACED TO LASER REP, COULD NOT REACH AT FIRST. CALL THEN PLACED TO CO AND SUBSEQUENTLY PUT ON "HOLD" FOR APPROX FIVE MINUTES. TROUBLESHOOTING CONTINUED BY REPLACING THE FIBER AGAIN TO NO AVAIL. ERROR MESSAGE CONTINUTED APPROX 10 MINUTES AND CONVERSATION ENSUED BETWEEN REP AND DR. CASE ABORTED AND REP SCHEDULED TO BE AT FACILITY ON 12/3/1998 TO CHECK OUT THE EQUIPMENT. THE ONLY PROCEDURE PERFORMED ON THE PT WAS A CYSTOURETHROSCOPY. DR TO PROVIDE EXPLANATION TO PT AND FAMILY. OPERATING ROOM MANAGER WAS MADE AWARE OF THIS ABOVE-DESCRIBED SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO PROSTATE LASER UROLOGIC LASER LNK INDIGO MEDICAL INC 830E / L583E *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other