BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDESCOPE GVL 4

    MDR report key: 2222973 · Received August 24, 2011

    Report

    Report Number
    MW5021829
    Event Type
    Death
    Date Received
    August 24, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 15, 2011
    Manufacturer
    VERATHON MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CODE BLUE ON NIGHT SHIFT, A CHIP WAS FOUND ON THE END OF THE GVL AND THEN THE GVL CRACKED AT THE SEAM AT THE TIP OF THE GVL AND BROKE IN HALF. USER IS NOT SURE IF THE BLADE BROKE PRIOR TO, OR DURING THE PROCEDURE. USER STATES THAT PT PASSED AWAY. THE PT DIDN'T DIE DUE TO ANY INJURIES CAUSED BY THE GVL BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDESCOPE GVL 4 GLIDESCOPE GVL 4 CCW VERATHON MEDICAL 0574-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O