BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT, 20" FLAT SPATULA /PADDLE

    MDR report key: 1621475 · Received February 19, 2010

    Report

    Report Number
    1621475
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 10, 2010
    Report Date
    February 19, 2010
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FROM SURGEON'S DICTATION, "DURING A LAPAROSCPOIC TUBAL LIGATION; THE RIGHT FALLOPIAN TUBE WAS IDENTIFIED,FOLLOWED TO ITS FIMBRIATED END, GRASPED (WITH THE TONGS) IN ITS MIDPORTION AND TRIPLY COAGULATED. AS THE METER TONGS(THE INSTRUMENT IN QUESTION) WERE BEING REMOVED, ONE OF THE "COMMON PADDLES" FELL OFF THE INSTRUMENT ONTO THE INTESTINE. THIS WAS GRASPED WITH AN ATRAUMATIC GRASPER AND PULLED OUT THROUGH THE LOWER PORT. FOLLOWING THIS THE TONGS WERE REPLACED AND THE OTHER TUBE WAS IDENTIFIED, FOLLOWED TO ITS FIMBRIATED END, GRASPED IN ITS MIDPORTION AND TRIPLY COAGULATED." MANUFACTURER RESPONSE (AS PER REPORTER) FOR KLEPPINGER, BIPOLAR INSERT, 20" FLAT SPATULA /PADDLENONE SO FAR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR INSERT, 20" FLAT SPATULA /PADDLE COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) HIN KARL STORZ ENDOSCOPY-AMERICA, INC. 26177KL EECM

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR