BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR

    MDR report key: 6882462 · Received September 21, 2017

    Report

    Report Number
    1216677-2017-00056
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    July 21, 2017
    Report Date
    December 15, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K954311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDWATCH UFI REPORT# (B)(4). (B)(6) 2016 - PT TAKEN TO OR FOR LAPAROSCOPIC VAGINAL HYSTERECTOMY. RUMI SYSTEM UTERINE MANIPULATOR USED. PROCEDURE CONVERTED TO OPEN, ABDOMINAL HYSTERECTOMY. (B)(6) 2017 - PT RETURNED TO OR FOR REMOVAL OF RETAINED KOH CUP THAT HAD BEEN INSERTED DURING (B)(6) 2016 PROCEDURE. PATHOLOGY DESCRIPTION-BLUE DEVICE CONSISTING OF 2 RINGS (4.2 CM AND 2.5 CM) CONNECTED BY THREE POLES. THE SPECIMEN MEASURES 3.4 CM IN HEIGHT. INSCRIPTION - "COOPERSURGICAL", KCP-35, 3.5 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665342 RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR, HEW COOPERSURGICAL, INC. KCP-35-2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O