BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 702898 · Received November 26, 2005

    Report

    Report Number
    1527736-2005-05755
    Event Type
    Malfunction
    Date Received
    November 26, 2005
    Date of Event
    November 17, 2005
    Report Date
    November 22, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A GASTRIC BYPASS PROCEDURE, THE ONE-PIECE SLED DISLODGED FROM THE CARTRIDGE. THE CAWE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WAS NOT PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 ENDO LINEAR CUTTERS - ECHELON 60MM KOG ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN