BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI SYSTEM

    MDR report key: 1131303 · Received August 5, 2008

    Report

    Report Number
    1131303
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 5, 2008
    Manufacturer
    COOPER SURGICAL
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DEVICE AND REUSABLE REMOVED FROM VAGINA AND PHYSICIAN DISCOVERED THAT THE END PIECE WAS MISSING. THE PHYSICIAN EXAMINED THE PATIENT AND REMOVED THE MISSING PIECE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUMI SYSTEM UTERINE MANIPULATOR LKF COOPER SURGICAL UMH600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR