BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFRANCE®

    MDR report key: 3854215 · Received June 6, 2014

    Report

    Report Number
    9680837-2014-00046
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (ISSUE ASSOCIATED WITH THE INAPPROPRIATE DELIVERY OF AN ELECTRICAL ENERGY). THE DEVICE HAS BEEN RETURNED TO MEDTRONIC INTERNATIONAL LOCATION AND WILL BE FORWARDED TO MXI FOR ANALYSIS/EVALUATION. METHOD : ACTUAL DEVICE NOT EVALUATED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    THE FORCEPS WERE SHORT CIRCUITED. AFTER DISASSEMBLY, IT APPEARS THAT THE SHORT CIRCUIT IS BETWEEN ONE OF THE WIRES AND THE TUBE OF THE ELECTRODE. THIS PART IS NOT IN CONTACT WITH THE PATIENT OR THE USER, THE ELECTRICAL RISK IS VERY LOW. THIS IS NOT THE CAUSE OF THE INCIDENT DESCRIBED BY THE SURGEON. DURING THE DISASSEMBLY, SURGICAL RESIDUES WERE OBSERVED BETWEEN THE BIPOLAR CONNECTORS, BETWEEN THE WIRES OF THE ELECTRODE AND AROUND THE TUBE. THE CAUSE OF THE SHORT CIRCUIT IS IN ALL LIKELIHOOD A WEAKNESS IN THE COATING DUE TO A DEFECT OF MANUFACTURING. THE BURN OF THE SURGEON IS PROBABLY DUE TO THE HEATING OF THE SURGICAL RESIDUES, WHICH LED TO OVERHEATING OF THE INSTRUMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, A LAPAROSCOPIC NEPHRECTOMY WAS PERFORMED ON A FEMALE PATIENT WITH A LEFT KIDNEY TUMOR USING A BIPOLAR CEV134. THE BIPOLAR FORCEPS WERE USED FROM THE START OF THE SURGERY. THE DEVICE WORKED NORMALLY THROUGHOUT MOST OF THE SURGERY, WHICH IN TOTAL WAS OF AROUND 3 HOURS AND 30 MINUTES. HOWEVER, TOWARD THE END OF THE SURGERY (APPROXIMATELY 3 HOURS AND 28 MINUTES INTO THE SURGERY), THE USER TRIED TO COAGULATE FAT TISSUE. THE USER REPORTED, ¿THE BIPOLAR NOT ONLY DIDN'T COAGULATE BUT ALSO PASSED ON AN ELECTRIC CHARGE ON MY LEFT HAND, THE ONE MANIPULATING THE BIPOLAR, AND CONSEQUENTLY BURNED THE METACARPAL PORTION OF THE SURGEONS FIRST FINGER OF THE LEFT HAND.¿ AFTER THIS EVENT, THE BIPOLAR FORCEPS WERE NO LONGER USED. THERE WAS NO INJURY TO THE PATIENT REPORTED.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE PATIENT WAS OK AT HER LAST CONSULTATION, JUNE 11, 2014. THE PATIENT HAD NO COMPLAINTS AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332797 MICROFRANCE® ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV134 140204

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR