BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS 45 ENDO LIN CUT RELOAD WH

    MDR report key: 1121898 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01154
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/13/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, THE RELOAD FIRED MALFORMED STAPLES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS 45 ENDO LIN CUT RELOAD WH GDW ETHICON ENDO-SURGERY, LLC NA E4K740

    Patients

    Seq Age Sex Outcome Treatment
    1