BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL

    MDR report key: 1721520 · Received June 8, 2010

    Report

    Report Number
    1721520
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 8, 2010
    Manufacturer
    SURGRX INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AN ENSEAL LOANER GENERATOR WAS BEING USED FOR ALMOST 1 HOUR WHEN IT STOPPED WORKING; MISFIRING, FIRING TOO QUICKLY, NOT FIRING. A NEW HANDLE WAS OPENED AND SURGERY WAS COMPLETED WITHOUT FURTHER OCCURRENCE.THE SALES REPRESENTATIVE WAS CONTACTED AND ALL PRODUCT NUMBER WAS PULLED FROM THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL ELECTROSURGICAL DEVICE GEI SURGRX INC * F09H17-01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR