BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIC

    MDR report key: 8216986 · Received January 4, 2019

    Report

    Report Number
    9680952-2018-00087
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    November 23, 2018
    Report Date
    January 4, 2019
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GEI
    UDI-DI
    05051986000411
    PMA / PMN Number
    K063485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SCISSOR WAS BEING USED TO DIATHERMY A SECTION OF ENDOMETRIOSIS AND THE CONSULTANT NOTICED SMOKE COMING FROM THE SHAFT OF THE INSTRUMENT AWAY FROM THE SITE OF DIATHERMY WHERE THE UTERUS WAS TOUCHING THE SHAFT. THEREFORE, THE CONSULTANT WAS AWARE THE INSTRUMENT MUST HAVE SHORTED OUT OF VIEW AND CAUSED A BURN TO THE UTERUS WHERE THE SHAFT WAS IN CONTACT WITH IT. ELECTRICAL SHORT CIRCUIT THROUGH THE FAULTY INSULATION CAUSED A SUPERFICIAL BURN TO THE UTERINE SEROSA. THIS WILL HAVE NO CONSEQUENCE TO THE PATIENT BUT IF THE BURN HAD BEEN ON THE BOWEL, BLADDER URETER OR FALLOPIAN TUBES, SERIOUS HARM COULD HAVE RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9438 LOGIC LOGICUT MINI SCISSOR GEI SURGICAL INNOVATIONS LTD 120-7500 724361 05051986000411

    Patients

    Seq Age Sex Outcome Treatment
    1 Other