BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1171562 · Received September 18, 2008

    Report

    Report Number
    3005075853-2008-01769
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/18/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS THAT DURING A GASTRIC BYPASS REVISION PROCEDURE, THE SURGEON WAS FIRING ACROSS GASTRIC TISSUE JUST PROXIMAL TO THE GASTRO JEJUNOSTOMY WITH A BLUE RELOAD. THE TISSUE SEEMED THICK AND POSSIBLY SCARRED. UPON FIRING THE FIRST DEVICE, THE HANDLE WENT LIMP AND THE DEVICE DID NOT CUT OR STAPLE. A SECOND DEVICE WAS OPENED AND UPON FIRING, THE HANDLE WENT LIMP AND PARTIALLY FIRED. THE STAPLES WERE MALFORMED. ANOTHER DIFFERENT DEVICE WAS OPENED AND IT ALSO PARTIALLY FIRED AND DELIVERED MALFORMED STAPLES. A SECOND DEVICE WAS OPENED AND IT MADE A SNAPPING NOISE AND PARTIALLY FIRED. NO BUTTRESSING MATERIAL WAS USED AND ALL DEVICES WERE USED WITH BLUE RELOADS. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1