BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1121563 · Received August 8, 2008

    Report

    Report Number
    1121563
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    February 25, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE LONG 45 AND 60 ENDOCUTTER, THE TISSUE DID NOT COME AWAY FROM THE STAPLE CARTRIDGE, ONCE WITH EACH GUN. NOTED, BLADE DID NOT RETRACT AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. H208LONG601U D4JX7N
    2 LONG 45 ENDOCUTTER STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ETS-FLEX45 E4K40Z

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR