BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICUT SCISSOR

    MDR report key: 8019077 · Received October 29, 2018

    Report

    Report Number
    MW5080904
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 26, 2018
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DEFECT IN THE INSULATION CAUSED A CAUTERY BURN TO THE PERINEUM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857784 LOGICUT SCISSOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SURGICAL INNOVATIONS LTD 718603

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other