BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 1181231 · Received September 29, 2008

    Report

    Report Number
    1717344-2008-00450
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DGPHP SITE BURNS CAN BE THE RESULT OF A NUMBER OF CAUSES INCLUDING PLACEMENT, DURATION OF TREATMENT AND POWER SETTINGS, PATIENT CONDITION, AND POTENTIALLY BY FAILURE OF THE DISPERSIVE ELECTRODE TO PERFORM AS INTENDED. IN THIS CASE, WITHOUT THE RETURN OF THE INCIDENT DISPERSIVE ELECTRODE, WE WERE UNABLE TO DETERMINE IF ANY DEFECT OF THE PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT. ONE OF THE CAUSES OF BURNS IS POOR DGPHP PLACEMENT. AS NOTED ABOVE, PROPER PLACEMENT OF THE DGPHP AND ENSURING GOOD CONTACT THROUGHOUT THE PROCEDURE (ESPECIALLY IF THE PATIENT IS REPOSITIONED) ARE CRITICAL COMPONENTS TO AVOIDING BURNS. THIS IS COVERED IN DETAIL IN OUR IFU. FURTHERMORE, WE ARE AWARE THAT SOME CUSTOMERS REUSE PADS EVEN THOUGH THEY ARE CLEARLY LABELED AS SINGLE USE DEVICES. REUSED DISPERSIVE ELECTRODES CAN DRY OUT AND BE A SOURCE FOR BURNS BECAUSE THEY DO NOT CONDUCT ELECTRICAL CURRENT PROPERLY. WE ARE CLOSELY MONITORING THE INCIDENCE RATE OF DISPERSIVE ELECTRODE BURNS. THE RATE OF BURNS FOR VALLEYLAB DGPHP DISPERSIVE ELECTRODES CONTINUES TO BE LOWER THAN THE OVERALL RATE OF RADIO FREQUENCY ABLATION DISPERSIVE ELECTRODE BURNS AS CITED IN CURRENT MEDICAL LITERATURE. CONTINUOUS IMPROVEMENT EFFORTS ARE ON-GOING TO ENSURE THAT CUSTOMERS ARE PROPERLY TRAINED AND OUR IFU CLEARLY ILLUSTRATES THE PROPER PLACEMENT OF THE DISPERSIVE ELECTRODES. WE ALSO REINFORCE THE IMPORTANCE OF NOT REUSING THESE SINGLE USE DEVICE TO THE CUSTOMER WHENEVER THE OPPORTUNITY ARISES.

    Description of Event or Problem · 1

    THE REPORT STATED THAT POST OPERATIVELY, A BURN WAS FOUND AT THE PAD SITE ON THE LEFT THIGH APPROXIMATELY WHERE PAD CORD WAS ATTACHED. IT WAS REPORTED AS A 3RD DEGREE AND 2CM X 4 CM IN SIZE. THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE GENERATOR REACHED A MAXIMUM OF 130W DURING 4 ABLATIONS FOR A TOTAL ABLATION TIME OF 40 MINUTES. TWO PADS WERE BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD ELECTROSURGICAL ACCESSORY ODR COVIDIEN LP (VALLEYLAB) 125352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other 2 ACT-2030-RF ABLATION NEEDLE ELECTRODES