BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60 ENDOPATH STAPLER

    MDR report key: 1802823 · Received August 10, 2010

    Report

    Report Number
    MW5017067
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ETHICON ENDO SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STAPLER FAILED TO FIRE WHEN RELOADED. DATES OF USE: #1 AND #2: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: #1 AND #2: USED IN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 60 ENDOPATH STAPLER STAPLER GDW ETHICON ENDO SURGERY, LLC EC60A
    2 ETHELON 60 ENDOSCOPIC LINEAR RELOADS GDW ETHICON ENDO-SURGERY, LLC ECR60B

    Patients

    Seq Age Sex Outcome Treatment
    1