BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI ARCH HANDLE

    MDR report key: 2860149 · Received November 21, 2012

    Report

    Report Number
    1216677-2012-00024
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UMH700, SERIAL # (B)(4) WAS MANUFACTURED IN JULY OF 2011 - PRIOR TO THE IMPLEMENTATION DATE OF (B)(4). THE DESIGN CHANGE ON (B)(4) ADDED A COUNTERBORE TO THE THROUGH HOLE WHICH PREVENTS THE RUMI TIP ROD FROM EXTENDING OUT OF THE BOTTOM SIDE OF THE ARCH DURING USE. (B)(4).

    Description of Event or Problem · 1

    DOCTOR (B)(6) WAS PERFORMING TOTAL ROBOTIC HYSTERECTOMY WITH ARCH (UMH700), KOH CUP AND UMB678 (8 CM TIP). AFTER PROCEDURE, AS HE WAS PULLING OUT THE HANDLE, THE KOH CUP CAME DETACHED. HE POPPED IT BACK ON AND BEGAN TO PULL OUT THE HANDLE AND THE ROD OF THE UMB678 ADVANCED OUT THE BACK OF THE HANDLE AND LACERATED THE PATIENT'S POSTERIOR VAGINAL WALL. DOCTOR REPAIRED LACERATION. PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUMI ARCH HANDLE NONE LKF COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention