BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM SCISSORS

    MDR report key: 662787 · Received November 29, 2005

    Report

    Report Number
    MW1037640
    Event Type
    Injury
    Date Received
    November 29, 2005
    Date of Event
    November 23, 2005
    Report Date
    November 29, 2005
    Manufacturer
    SURGICAL PRINCIPALS, INC
    Product Code
    LRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS CAUTERIZING ENDOMETRIAL IMPLANTS USING AEM SCISSORS. ALL EQUIPMENT FUNCTIONING CORRECTLY. SURGEON NOTICED CAPACITANCE COUPLING AT AEM SCISSORS TO NON INSULATED PORTION OF GRASPER WHICH RESULTED IN A SUPERFICIAL BURN TO THE LEFT FALLOPOIAN TUBE. AEM IS SUPPOSED TO DISABLE SELF IF INSULATION IS NOT INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SCISSORS * LRW SURGICAL PRINCIPALS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR