BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE KOH COLPOTOMIZER SYSTEM

    MDR report key: 2001145 · Received February 7, 2011

    Report

    Report Number
    2001145
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    August 2, 2010
    Report Date
    January 19, 2011
    Manufacturer
    COOPERSURGICAL - THE KOH COLPOTOMIZER SYSTEM
    Product Code
    HEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A SCHEDULED LAPROSCOPIC HYSTERECTOMY. THE TWO PIECE COLPOTOMIZER AND UTERINE MANIPULATOR WERE INSERTED INTO THE VAGINA. DUE TO SEVERE LESIONS, THE DECISION WAS MADE TO CONVERT TO AN OPEN PROCEDURE. THE UTERINE MANIPULATOR WAS TAKEN OUT, COLPOTOMIZER LEFT IN VAGINA. BY LEAVING THE COLPOTOMIZER IN FOR APPROXIMATELY SIX WEEKS, IT LED TO AN INFECTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE KOH COLPOTOMIZER SYSTEM COLPOTOMIZER HEW COOPERSURGICAL - THE KOH COLPOTOMIZER SYSTEM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO OTHER THERAPIES