BEUDAMED
    FDA Adverse Event Summary report: N

    SUCTION COAGULATOR

    MDR report key: 1862543 · Received September 17, 2010

    Report

    Report Number
    1862543
    Date Received
    September 17, 2010
    Date of Event
    May 25, 2010
    Report Date
    September 14, 2010
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE CAUTERIZING THE ADENOID, THE SURGEON FELT A SHARP STICK ON HER INDEX FINGER WHERE SHE COVERED THE SUCTION HOLE ON A SUCTION COAGULATOR. SHE EXAMINED THE GLOVE AND FOUND A TINY BURN HOLE IN HER GLOVE. SHE TOOK THE GLOVE OFF TO EXAMINE HER FINGER AND NOTICED PINPOINT BLACK DOT ON HER FINGER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT SURE====================== MANUFACTURER RESPONSE FOR VALLEY LAB SUCTION COAGULATOR PER SITE REPORTER======================VALLEYLAB NEWSLETTER VOL 10, ISSUE 1, JAN. 2005, CLINICAL INFORMATION HOTLINE NEWS: "SIMULTANEOUSLY ACTIVATING SUCTION/IRRIGATION AND ELECTROSURIGICAL CURRENT MAY RESULT IN INCREASED ARCING AT THE ELECTRODE TIP, BURNS TO UNINTENDED TISSUES, OR SHOCKS AND BURNS TO THE SURGICAL TEAM."VALLEYLAB NEWSLETTER, VOL 4, ISSUE 1, MARCH 1999, CLINICAL INFORMATION HOTLINE NEWS: "HIGH FREQUENCY CURRENT CAN CREATE PIN-POINT BURNS THAT ARE PERCEIVED TO BE SHOCKS." "CURRENT MIGHT CONCENTRATE AT INTERFACING POINTS AND WILL BE FELT AS A SHOCK OR BURN." "ACTIVATE ELECTRODE ONLY IF IT IS TOUCHING OR IN CLOSE PROXIMITY TO TARGET TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION COAGULATOR SUCTION COAGULATOR GEI COVIDIEN VALLEYLAB E2505-10FR *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR