BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 6459777 · Received April 3, 2017

    Report

    Report Number
    MW5068892
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 22, 2017
    Report Date
    April 3, 2017
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    PLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ETHICON STAPLER WITH RELOAD LOCKED UP WHILE IN USE. ETHICON REPRESENTATIVE WAS AVAILABLE TO ASSIST SURGEON IN RELEASING STAPLER AND REMOVAL OF THE LOAD. REPLACEMENT DEVICE WAS MADE AVAILABLE. NO ADVERSE EVENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237693 ETHICON ECHELON FLEX POWERED PLUS STAPLER PLE ETHICON ENDO-SURGERY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR