BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER (STANDARD) - 35 MM

    MDR report key: 1080530 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00430
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 20, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ZENKERS DIVERTICULUM PROCEDURE, THE DEVICE FIRED SOME MALFORMED STAPLES. THE STAPLE WAS PULLED OUT AND SINCE IT WAS VERY DISTAL OR PROXIMAL NO ADD'L ACTION WAS NEEDED. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER (STANDARD) - 35 MM NONE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1