BEUDAMED
    FDA Adverse Event Summary report: N

    LAP LOOP ELECTRODE

    MDR report key: 3949106 · Received May 23, 2014

    Report

    Report Number
    3949106
    Date Received
    May 23, 2014
    Date of Event
    July 14, 2010
    Report Date
    May 23, 2014
    Manufacturer
    MARKET-TIERS, INC. D/B/A BLUE ENDO
    Product Code
    KNF
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY APPROXIMATELY FOUR YEARS AGO. THE PATIENT WAS COMPLAINING OF PAIN IN HER BACK AND PELVIS. LAST YEAR, A CT-SCAN REVEALED A 4.5 MM PLASTIC TUBE IN HER PELVIS. RECENTLY, THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY DURING WHICH THE 4.5 MM PIECE OF PLASTIC TUBING WAS REMOVED. THIS WAS IDENTIFIED AS THE TIP OF THE HUMI UTERINE MANIPULATOR THAT IS INSERTED INTO THE UTERUS DURING A SUPERFICIAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307801 LAP LOOP ELECTRODE ELECTRODE KNF MARKET-TIERS, INC. D/B/A BLUE ENDO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR