BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3252617 · Received July 15, 2013

    Report

    Report Number
    1717344-2013-00513
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 10, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GROUNDING PAD WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. 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 PATIENT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK. THE DISTRIBUTOR REPORTED THAT THE RF3000 ABLATION GENERATOR USER'S MANUAL STATES SKIN-TO-SKIN CONTACT SHOULD BE AVOIDED IN ORDER TO REDUCE THE LIKELIHOOD OF PATIENT BURNS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT'S THUMB WAS TOUCHING HIS BODY NEAR ONE OF FOUR GROUNDING PADS USED DURING AN ABLATION PROCEDURE. THIS RESULTED IN A 2ND DEGREE BURN TO THE PATIENT'S THUMB. THE BURN WAS TREATED WITH BIAFINE CREAM. THE PADS WERE PLACED ON THE PATIENT'S THIGHS. THE INCIDENT PAD IS NOT BEING RETURNED FOR EVALUATION. IT WAS DISCARDED BY THE SITE FOLLOWING THE PROCEDURE. A BOSTON SCIENTIFIC RF3000 ABLATION GENERATOR WAS IN USE FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328029 POLYHESIVE RETURN ELECTRODE PATIENT GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BOSTON SCIENTIFIC ABLATION GENERATOR: SN (B)(4)