BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1662658 · Received April 14, 2010

    Report

    Report Number
    MW5015576
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 14, 2010
    Manufacturer
    CQ LABS
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BYPASS WHILE USING A MULTI-USE DEVICE, THE SURGEON USED THE DEVICE ONCE. THE DEVICE WAS REMOVED FROM THE PT'S ABDOMEN FOR RELOAD AND SECOND USE. THE TECHNOLOGIST COULD NOT GET THE DEVICE TO OPEN TO REMOVE EXPENDED LOAD FOR RELOAD. A NEW DEVICE WAS ACQUIRED AND THE PROCEDURE CONTINUED WITH MINIMAL DELAY. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON STAPLER GDW CQ LABS SC60A G4R72H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability