BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFFICIENT, RUMI 3.5CM

    MDR report key: 3072603 · Received April 19, 2013

    Report

    Report Number
    1627186-2013-00005
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW OF LOT# 138986 SHOWS ALL PRODUCTS WERE MANUFACTURED AND TESTED PER ESTABLISHED PROCEDURES AND THERE WERE NO SIGNIFICANT ISSUES IDENTIFIED EITHER DURING MANUFACTURING, ASSEMBLY OR TESTING. RECEIVING INSPECTIONS PERFORMED ON COMPONENT LOTS OF KOH CUPS, SLEEVES, SLEEVE EXTENSIONS AND HINGE ADAPTORS ALSO DID NOT SHOW ANY SIGNIFICANT ISSUES. COOPERSURGICAL'S CHIEF MEDICAL OFFICER SPOKE TO DR (B)(6) REGARDING THE EVENT. HIS ANALYSIS STATES "GIVEN THAT THE BLEEDING OCCURRED DURING THE MANIPULATION PHASE AND THE LACERATION WAS AT THE APEX OF THE VAGINA, IT IS LIKELY THAT THE TORQUE NEEDED TO EXPOSE THE VASCULATURE IN THIS BROAD UTERUS CAUSED THE LEADING EDGE OF THE KOH CUP TO TEAR AGAINST THE VAGINAL TISSUE WITH STROPHY CONTRIBUTING TO THIS TEAR. ALTHOUGH PERHAPS THE 3.5 CUP WAS CORRECT IN SIZE, THIS IS A LARGE DIAMETER FOR THE AVERAGE (B)(6) PATIENT - BUT EVERY OPERATIVE ANATOMY CAN BE DIFFERENT. THERE IS NO SUGGESTION THAT THE KOH EFFICIENT SLEEVE OR HINGE CONTRIBUTED TO THE EVENT - THE TIMING AND LOCATION OF THE LACERATION ALSO SPEAKS AGAINST ANY CONTRIBUTION OF THE SLEEVE PORTION OF THE DEVICE." (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED A ROBOTIC TOTAL HYSTERECTOMY ON A (B)(6) WOMAN. AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTED EXCESSIVE VAGINAL BLEEDING AND 2 LACERATIONS ON EACH SIDE. THE PATIENT REQUIRED SUTURES AND 3 UNITS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170658 KOH-EFFICIENT, RUMI 3.5CM NONE KOH COOPERSURGICAL, INC. 138986

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention