BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 17126604 · Received June 14, 2023

    Report

    Report Number
    1216677-2023-00094
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 21, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    UDI-DI
    888937015232
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, H5, H8 ADDITIONAL CORRESPONDANCE FROM THE REPORTER CONFIRMED THAT THE DEVICE BROKE AND WAS REPLACED OUTSIDE OF SURGICAL SITE. DEVICE NOT USED INSIDE OF SURGICAL SITE AND HAS NO POTENTIAL TO FRAGMENT INSIDE OF PATIENT'S BODY. UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR HAVE THE POTENTIAL TO CAUSE, AN ADVERSE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR HAVE THE POTENTIAL TO CAUSE, AN ADVERSE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 1216677-2023-00094-1 UMH650 RUMI II 2023-06-0000105.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, THE DEVICE BROKE INTO TWO PIECES. PIECES WERE REMOVED WITHOUT INJURY TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2023-00094 UMH650 RUMI II 2023-06-0000105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875027 RUMI II,BACKLOADABLE UTERINE MANIPULATOR, SINGLE-USE LKF COOPERSURGICAL, INC. UMH650 21407304 888937015232

    Patients

    Seq Age Sex Outcome Treatment
    1 Female