BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 1233443 · Received November 12, 2008

    Report

    Report Number
    1717344-2008-00528
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    September 15, 2008
    Report Date
    November 6, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU UNDER "INTENDED USE" STATES: ALL VALLEYLAB PT RETURN ELECTRODES ARE DESIGNED FOR USE IN TRADITIONAL MONOPOLAR SURGICAL PROCEDURES WITH DUTY CYCLES OF 25% OR LESS (FOR EXAMPLE: 10 SECONDS FOLLOWED BY 30 SECONDS OFF). DURING A SURGICAL PROCEDURE, THE AMOUNT OF CURRENT DELIVERED IN GIVEN TIME DETERMINES THE AMOUNT OF HEAT THAT OCCURS UNDER THE ELECTRODE. IT IS NOT POSSIBLE TO FORESEE WHAT COMBINATION OF CURRENT. AND DUTY CYCLE MAY BE SAFELY USED IN EVERY SITUATION. WHEN USING A VALLEYLAB PT RETURN ELECTRODE, THE USER SHOULD CONSULT THE GENERATOR AND ACCESSORY MFRS' RECOMMENDATIONS AND TECHNICAL SPECS REGARDING RECOMMENDED MAXIMUM DUTY CYCLES. THE IFU THEN WARNS THAT PROCEDURES THAT UTILIZE HIGH CURRENT AND/OR LONG DUTY CYCLES (SUCH AS TISSUE ABLATION) INCREASE THE RISK OF EXCESSIVE HEATING TO THE POINT OF INJURING THE PT. THE IFU ALSO INDICATES " DO NOT ALLOW ADJOINING EDGES TO TOUCH OR OVERLAP."

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH, THE PT WAS BURNED AT THE PAD SITE DURING A CARDIAC ABLATION PROCEDURE USING A BOSTON SCIENTIFIC MAESTRO 3000 CARDIAC ABLATION SYS. ALTHOUGH THE CATALOG NUMBER OF THE PAD WAS NOT KNOWN BY THE CUSTOMER, IT IS BELIEVED TO BE AN E7506 PAD SINCE BOSTON SCIENTIFIC HAS BEEN KNOWN TO USE THIS PAD WITH THEIR ABLATION GENERATORS. THE PADS WERE PLACED ADJACENT TO EACH OTHER ON THE PT'S LEFT BUTTOCK. IT IS BELIEVED THE PADS LIFTED AND CREATED A HOT SPOT BETWEEN THE PADS, CAUSING THE BURN. THE BURN WAS NOTICED FOLLOWING COMPLETION OF THE PROCEDURE. THE BURN SIZE WAS 12 CM X 8 CM AND REQUIRED DEBRIDEMENT AND SURGICAL EXCISION. THE INCIDENT PADS WERE DISCARDED BY THE SITE. SOMETIME AFTER RELEASE FROM THE HOSP, THE PT WAS TREATED FOR A SUPERFICIAL INFECTION AT THE BURN SITE, BUT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE RETURN ELECTRODE ELECTROSURGICAL ACCESSORY ODR COVIDIEN LP (VALLEYLAB) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other