BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1210073 · Received October 22, 2008

    Report

    Report Number
    3005075853-2008-02514
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 29, 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: 10/22/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PULMONARY COLECTOMY PROCEDURE, AFTER STAPLING AND REMOVING THE DEVICE IT WAS OBSERVED THAT THE STAPLES WERE PARTIALLY OPEN. THE STAPLES DID NOT HOLD BRONCHUS WALL IN ALL ITS THICKNESS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4F79J

    Patients

    Seq Age Sex Outcome Treatment
    1