BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.S. UNIT, FORCE 2-20PC USED

    MDR report key: 795568 · Received December 14, 2006

    Report

    Report Number
    1717344-2006-00347
    Event Type
    Injury
    Date Received
    December 14, 2006
    Date of Event
    June 30, 2004
    Report Date
    November 16, 2006
    Manufacturer
    VALLEYLAB - QA
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF VALLEYLAB ANALYSIS. SUBSEQUENT TESTING BY A TYCO HEALTHCARE SERVICE FACILITY SHOWED THE HF LEAKAGE TO BE NORMAL AND WITHIN THE LIMITS SPECIFIED BY THE INTERNATIONAL STANDARD IEC 60601-2-2. AN INCORRECT TEST PROCEDURE BY THE HOSPITAL WOULD EXPLAIN THE HIGH READINGS. IF HF LEAKAGE CURRENT HAD TRAVELED IN THE PATIENT'S LEFT LEG, THE LEG WOULD HAVE TO HAVE BEEN GROUNDED AND THERE WOULD HAVE BEEN AN EXIT BURN AT THE GROUNDING POINT. WITH NO REPORT OF VISIBLE MARKS ON PATIENT'S LEFT LEG AND THE NORMAL HF LEAKAGE MEASUREMENTS, VALLEYLAB BELIEVES THE ALLEGED INJURY IS DUE TO SOME OTHER CAUSE THAN THE USE OF THE FORCE 2 GENERATOR.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT UNDERWENT ABDOMINAL SURGERY USING VALLEYLAB FORCE 2 GENERATOR AND UNKNOWN RETURN ELECTRODE APPLIED AT SITE OTHER THAN LEFT LEG. NOTHING UNUSUAL REPORTED DURING SURGERY. AT SOME TIME LATER, PATIENT ALLEGED DAMAGE TO FEMORAL NERVE IN LEFT LEG. HOSPITAL TESTED FORCE 2 AND ALLEGES EXCESSIVE HF (HIGH FREQUENCY) LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.S. UNIT, FORCE 2-20PC USED ELECTROSURGICAL DEVICE GEI VALLEYLAB - QA * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention