BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS-ECHELON 60MM

    MDR report key: 726390 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02701
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    March 2, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K05102.

    Description of Event or Problem · 1

    ON THE ELEVENTH FIRING THE STAPLES DID NOT FORM. THE CUSTOMER USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO LINEAR CUTTERS-ECHELON 60MM GDW GDW ETHICON ENDO SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN