BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 1220777 · Received October 31, 2008

    Report

    Report Number
    1717344-2008-00489
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    ODR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THIS PRODUCT WAS RETURNED FOR A COSMETIC DEFECT. HOWEVER, WHEN THE SAMPLE WAS EVALUATED, IT WAS FOUND TO HAVE NO ELECTRICAL CONTINUITY DUE TO A STRESS FRACTURE IN THE FOIL AT THE TAB END OF THE ELECTRODE. A STRESS FRACTURE AT THE TAB END OF THE ELECTRODE WITH RESULTANT NON ELECTRICAL CONTINUITY HAS THE POTENTIAL TO CAUSE A PT BURN. A FAILURE ANALYSIS INTO THE OCCURRENCE OF STRESS FRACTURES FOUND THAT THEY COULD BE INDUCED BY MANIPULATION OF THE TAB DURING ASSEMBLY, APPLICATION TO THE PT AND REMOVAL FROM THE PT. ADDITIONALLY, A DEVICE THAT HAS BEEN REUSED AND SUBJECTED TO MULTIPLE MANIPULATIONS HAS A MUCH GREATER CHANCE OF INCURRING A STRESS FRACTURE. 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 ON THE PROPER USE OF THE DISPERSIVE ELECTRODES. WE ALSO REINFORCE THE IMPORTANCE OF NOT REUSING THESE SINGLE USE DEVICES TO THE CUSTOMER WHENEVER THE OPPORTUNITY ARISES. ADDITIONALLY, IN MARCH 2007, MFG IMPROVEMENTS WERE IMPLEMENTED TO REDUCE THE POSSIBILITY OF STRESS FRACTURES.

    Description of Event or Problem · 1

    THE INITIAL REPORT STATED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, WHEN THE OUTPUT WAS TURNED UP TO 15-20W, THE DEVICE SHUT OFF. ANOTHER CT2030 NEEDLE ELECTRODE WAS USED BUT THE IMPEDANCE DISPLAYED AS HH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE ELECTRODE ACT2030. THERE WAS NO BURN INJURY. THE PT IS REPORTED AS "OK". UPON RETURN OF THE DISPOSABLE SAMPLES, DURING THE INVESTIGATION, IT WAS DISCOVERED BOTH OF THE TWO PTS RETURNED ELECTRODES (PADS) WERE DEGRADED AND DID NOT HAVE ANY RESISTANCE. SEE MFR REPORT # 1717344-2008-00490 FOR THE OTHER PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD ELECTROSURGICAL ACCESSORY ODR COVIDIEN LP (VALLEYLAB) IN3162

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACT2030, LOT #UNK| ELECTRODES: CT2030, LOT #101603| COOLTIP GENERATOR, (B) (4)| CT2030, LOT #106166