BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE VASCULAR LINEAR STAPLER

    MDR report key: 1080461 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00415
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 19, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PEDIATRIC LOBECTOMY PROCEDURE, THE DEVICE FIRED, BUT NO STAPLES CAME OUT. USED A SECOND LIKE DEVICE TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE VASCULAR LINEAR STAPLER NONE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1