BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 2842747 · Received November 16, 2012

    Report

    Report Number
    2842747
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER WAS PLACED ON THE TISSUE AND DID NOT FIRE. THE OVERRIDE TO RELEASE DID NOT WORK. NO POWER TO REVERSE OPEN OR RELEASE STAPLER. THE REP WAS CALLED AND SUGGESTED TAKING OUT BATTERY PACK AND RE-INSERTING BATTERY PACK AND THEN STAPLER RELEASED.======================MANUFACTURER RESPONSE FOR ETHICON ECHELON STAPLER 60 MM, ETHICON ECHELON STAPLER (PER SITE REPORTER).======================THE REP RECOMMENDED TO REMOVE THE BATTERY PACK AND REPLACE IT. THE REP WILL COME TO PICK UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON STAPLER GDW ETHICON ENDO-SURGERY * J4C67X

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR