BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1880120 · Received October 22, 2010

    Report

    Report Number
    1527736-2010-00078
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ONE PICTURE WAS RECEIVED AND NO CONCLUSION COULD BE REACHED AS NO DEVICE WAS RECEIVED FOR ANALYSIS. NO DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ONE STAPLE DID NOT FORM PROPERLY ON THE DISTAL PART OF THE STAPLE LINE. UNKNOWN WHAT COLOR CARTRIDGE THEY WERE USING. THE SURGEON OVER SEWED THE AREA. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1