BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3810439 · Received April 14, 2014

    Report

    Report Number
    1717344-2014-00314
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Report Date
    March 24, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GROUNDING PAD WAS DISCARDED BY THE SITE 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 PT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GROUNDING PAD WAS BUBBLING UP AND CAUSING AN INJURY TO THE PT. THE PAD WAS PLACED FLAT ON THE PT'S THIGH. THE INJURY WAS DESCRIBED AS A BURN. THE PROCEDURE WAS A PVI ABLATION. THE INCIDENT GROUNDING PAD WAS DISCARDED. THE CUSTOMER HAS INDICATED NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228120 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP 33640097X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK