BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3001434 · Received February 26, 2013

    Report

    Report Number
    3001434
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BEFORE USING A 75MM LINEAR CUTTER FOR AN OPEN ABDOMINAL CASE ON THE PATIENT, THE SURGICAL TECH NOTICED THAT A SMALL WASHER HAD BROKEN OFF FROM THE INSTRUMENT. IT WAS REMOVED FROM THE FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RESECTION MALIGNANT NEOPLASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81570 * STAPLER, SURGICAL GAG ETHICON ENDO-SURGERY, LLC * JAC74X

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR