BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60

    MDR report key: 3111473 · Received May 8, 2013

    Report

    Report Number
    MW5030113
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ETHICON ENGO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE THIRD STAPLE WE USED WITH THE ECHELON FLEX 60 DID NOT FIRE PROPERLY. MORE STAPLES AND A NEW ECHELON WERE NEEDED TO FIX THE PROBLEM. REASON FOR USE: LAPAROSCOPIC ROUX EN Y GASTRIC BANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200193 ECHELON FLEX 60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, 440MM GDW ETHICON ENGO-SURGERY, LLC LONG60A K4CH96

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR