BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPORT LAPAROSCOPIC SYSTEM

    MDR report key: 1971139 · Received January 18, 2011

    Report

    Report Number
    1971139
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    GELPORT TORE AROUND THE BASE WHERE IT ATTACHES TO ALEXIS RETRACTOR; A NEW GELPORT WAS ADDED TO THE FIELD TO REPLACE THE BROKEN ONE AND THE CASE PROCEEDED WITHOUT PROBLEM.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DON'T KNOW.====================== MANUFACTURER RESPONSE FOR GELPORT LAPAROSCOPY SYSTEM, GELPORT LAPAROSCOPIC SYSTEM======================MANUFACTURERS REPRESENTATIVE WILL MAIL A SURVEY AND ONCE WE COMPLETE IT, HE WILL MAIL FEDEX SHIPPING INFORMATION TO SEND THE GELPORT TO APPLIED MEDICAL FOR REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT LAPAROSCOPIC SYSTEM GELPORT LAPAROSCOPY SYSTEM GCJ APPLIED MEDICAL * 1133383

    Patients

    Seq Age Sex Outcome Treatment
    1 *