BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3101848 · Received May 1, 2013

    Report

    Report Number
    1717344-2013-00313
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    January 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GROUNDING PAD WAS DISCARDED BY THE SITE AND WAS NOT AVAILABLE FOR EVAL. THE E7506 INSTRUCTIONS FOR USE WARNS THAT NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATION, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT THE RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PT BURN OCCURRED ON THE RIGHT LOWER QUADRANT FROM WHERE THE GROUNDING PAD WAS PLACED. THE DEGREE OF BURN AND TYPE OF TREATMENT ARE UNK. INCIDENT PAD WAS DISCARDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190347 POLYHESIVE RETURN ELECTRODE PATIENT GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR