BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEXIS CONTAINED EXTRACTION SYSTEM

    MDR report key: 8339481 · Received February 13, 2019

    Report

    Report Number
    MW5084061
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 7, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL HYSTERECTOMY FOR PATIENT WITH EARLY STAGE ENDOMETRIAL CANCER USING ALEXIS CONTAINED EXTRACTION SYSTEM FOR REMOVAL OF UTERUS. THE BAG APPARENTLY BROKE WITH MORCELLATED PIECES OF UTERUS SPILLING. THOUGH RISK DEEMED LOW FOR INTRA-PERITONEAL SPREAD, THERE IS NO WAY TO BE SURE. IN LIGHT OF THAT, DECISION MADE TO ADD VAGINAL BRACHYTHERAPY TO TREATMENT PLAN, WHICH WAS NOT PART OF THE INITIAL TREATMENT PLAN FOR THIS PATIENT. EXAMINATION OF THE BAG REVEALS STRETCHING AT THE SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127592 ALEXIS CONTAINED EXTRACTION SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP 1341272

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R