BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALLEYLAB

    MDR report key: 276244 · Received April 28, 2000

    Report

    Report Number
    276244
    Event Type
    Death
    Date Received
    April 28, 2000
    Date of Event
    April 17, 2000
    Report Date
    April 27, 2000
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIST WAS REMOVING A COLON POLYP USING VALLEYLAB CAUTERY, MICROVASIVE HOT BIOPSY FORCEP AND VALLEYLAB REM POLYHESIVE II GROUND PAD ON THE PT'S RIGHT THIGH. SEVERAL POLYS HAD ALREADY BEEN REMOVED. DURING THE LAST POLYP REMOVAL, THE PT CRIED OUT STATING THAT THEY FELT A SHOCK GO THROUGH THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB FORCE 1 CAUTERY GEI VALLEYLAB Z4G3811B *
    2 MICROVASIVE RADIAL JAW 3-1550 KNS BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O