BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXIS CONTAINED EXTRACTION SYSTEM WITH KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 6906706 · Received October 2, 2017

    Report

    Report Number
    6906706
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    July 5, 2017
    Report Date
    September 8, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTAINED EXTRACTION SYSTEM WAS BEING USED TO RETAIN UTERINE FIBROIDS WHICH WERE REMOVED FROM PATIENT'S UTERUS. ON REMOVAL OF THE EXTRACTION SYSTEM, THE BAG BROKE. A SMALL PIECE OF BAG WAS FOUND ON THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687071 ALEXIS CONTAINED EXTRACTION SYSTEM WITH KII BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. GTK17 1292020

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR