BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4696010 · Received April 15, 2015

    Report

    Report Number
    9680837-2015-00033
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Report Date
    March 20, 2015
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (1) GAYET BIPOLAR INSERT (CEV636-1A); LOT: 141101; MANUFACTURED: NOVEMBER 2014; 510K: K993655 (2) GAYET BIPOLAR INSERT (CEV636-1A); LOT: 140804; MANUFACTURED: AUGUST 2014; 510K: K993655 (3) 5MM DIA ANG BIPOLAR HANDLE (CEV669B); LOT: 141103; MANUFACTURED: NOVEMBER 2014; 510K: K993655 (4) 5MM DIA 310MM TUBE (CEV6795B); LOT: 140903; MANUFACTURED: SEPTEMBER 2014; 510K: K993655 (5) 5MM DIA 310MM TUBE (CEV6795B); LOT: 140901; MANUFACTURED: SEPTEMBER 2014; 510K: K993655. NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4). BURN OF DEVICE OR DEVICE COMPONENT. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, 6 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): CEV636-1A (LOT 141101) ¿ ANALYSIS FOUND THE INSERT ON SHORT CIRCUIT, THE WIRES OF THE ELECTRODE WERE UNGLUED FROM THE TUBE, THE BIPOLAR CONNECTOR WAS DISTORTED, AND ALTHOUGH THE INSULATION WAS COMPROMISED¿THE INTEGRITY WAS NOT, AS THIS DEFECT WAS DETERMINED NOT TO BE DANGEROUS FOR THE PATIENT/USER. THE MOST PROBABLE CAUSE IS THE USE OF EXCESSIVE FORCE ON THE INSERTS DURING ASSEMBLY WITH THE RETURNED DEFECTIVE HANDLE, AND THE SHORT CIRCUIT IS DUE TO THE MOVEMENT OF THE WIRES IN THE TUBE. CEV636-1A (LOT 140804) ¿ ANALYSIS FOUND THE INSERT ON SHORT CIRCUIT, THE WIRES OF THE ELECTRODE WERE UNGLUED FROM THE TUBE, THE BIPOLAR CONNECTOR WAS DISTORTED, AND ALTHOUGH THE INSULATION WAS COMPROMISED¿THE INTEGRITY WAS NOT, AS THIS DEFECT WAS DETERMINED NOT TO BE DANGEROUS FOR THE PATIENT/USER. THE MOST PROBABLE CAUSE IS THE USE OF EXCESSIVE FORCE ON THE INSERTS DURING ASSEMBLY WITH THE RETURNED DEFECTIVE HANDLE, AND THE SHORT CIRCUIT IS DUE TO THE MOVEMENT OF THE WIRES IN THE TUBE. CEV669B (LOT 141103) ¿ ANALYSIS FOUND IT VERY DIFFICULT TO ASSEMBLE THE HANDLE WITH AN INSERT DUE TO ITS SIZING, WHICH IS DESIGNED TO IMPROVE THE WATER TIGHTNESS OF THE HANDLE. THE DEVICE PASSED ELECTRICAL TESTS. CEV669B (LOT 140907) ¿ ANALYSIS FOUND THE BLACK PLASTIC PART WAS BURNT AT THE CONNECTION WITH THE CABLE AS A RESULT OF THE FORMATION OF AN ELECTRIC ARC DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE, WHICH MAY COME FROM A CLEANING OR DRYING DEFECT OF THE INSTRUMENT. THE DEVICE FAILED ELECTRICAL TESTS. CEV6795B (LOT 140903) ¿ ANALYSIS FOUND NO HIGHLIGHTED ISSUE; THE TUBE IS COMPLIANT WITH MANUFACTURING SPECIFICATIONS. CEV6795B (LOT 140901) ¿ ANALYSIS FOUND NO HIGHLIGHTED ISSUE; THE TUBE IS COMPLIANT WITH MANUFACTURING SPECIFICATIONS. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    A 5MM ANGLED BIPOLAR HANDLE WAS RETURNED TO MEDTRONIC AND UPON EVALUATION AND IT WAS OBSERVED THAT THE BLACK PLASTIC PART ON THE DEVICE WAS BURNT AT THE CONNECTION WITH THE CABLE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249939 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 140907

    Patients

    Seq Age Sex Outcome Treatment
    1