BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSTATE 2

    MDR report key: 536599 · Received July 8, 2004

    Report

    Report Number
    536599
    Event Type
    Other
    Date Received
    July 8, 2004
    Date of Event
    June 23, 2004
    Report Date
    June 24, 2004
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVENT DESC: DURING GASTRO INTESTIONAL PROCEDURE (POLYP REMOVAL), THE PHYSICIAN ACTIVATED PEDAL OF CAUTERY WITH NO RESPONSE. CONNECTIONS VISUALIZED AND CAUTERY MISFIRED. COLON RESECTION WAS THEN NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTATE 2 CAUTERY GEI MEDICAL SCIENTIFIC, INC. D2067 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other