BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 3875186 · Received June 11, 2014

    Report

    Report Number
    3875186
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LAPAROSCOPIC VAGINAL HYSTERECTOMY WAS PERFORMED UTILIZING THE SONICISION CORDLESS ULTRASONIC DISSECTOR. AT ONE POINT IN THE SURGERY WHILE THE CERVIX WAS BEING SEPARATED FROM THE VAGINA A PIECE OF ONE OF THE BLADES WAS FOUND TO BE MISSING. RETRIEVAL OF THE PIECE RESULTED IN EXTENSION OF THE SURGERY TO A LAPAROTOMY, MULTIPLE CARDIOLOGIC STUDIES (THE PIECE KEPT MOVING), PROLONGED TIME UNDER ANESTHESIA AND INVOLVEMENT OF A GENERAL SURGEON FOR REMOVAL. THE PIECE WAS REMOVED BUT REQUIRED INPATIENT DAYS RELATED TO THE PROLONGED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343867 COVIDIEN SONICISION ULTRASONIC DISSECTOR LFL COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O