BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2853263 · Received November 27, 2012

    Report

    Report Number
    2853263
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARTHROCARE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON GRASPED ROTATOR CUFF WITH CONNECTOR, CLOSED JAWS AND FIRED. WHEN PULLING OUT GUN SURGEON NOTICED THAT THE SUTURE CARTRIDGE HAD SEPARATED. PART OF THE SUTURE WAS IN THE TIP AND THE OTHER IN THE SHAFT, WHICH WAS STILL ATTACHED TO THE GUN.======================MANUFACTURER RESPONSE FOR SMARTSTITCH PERFECT PASSER SUTURE CARTRIDGE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================SPOKE TO REPRESENTATIVE. HE WANTED PRODUCT, BUT I WILL HOLD PRODUCT IN MY OFFICE. THE MANUFACTURER IS WELCOME TO COME IN AND TAKE PICTURES AND EVALUATE PRODUCT IN THE RISK MANAGER'S PRESENCE. WE WILL NOT RELEASE THE PRODUCT UNTIL I FEEL CONFIDENT THAT THERE IS NO PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ENDOSCOPE KOG ARTHROCARE * 1023281

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR