BEUDAMED
    FDA Adverse Event Other Summary report: N

    COHEN CANNULA WITH ACORN

    MDR report key: 725221 · Received May 30, 2006

    Report

    Report Number
    725221
    Event Type
    Other
    Date Received
    May 30, 2006
    Date of Event
    April 4, 2006
    Report Date
    May 30, 2006
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    LKF
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTICE THAT THE DEVICE WAS REMOVED FROM THE PT.'S VAGINA APPROXIMATELY FOUR DAYS POST-OP FOR A LAPAROSCOPIC TUBAL CAUTERIZATION. IT WAS DETERMINED THROUGH INVESTIGATION THAT THE DEVICE, A CERVICAL CONE WHICH IS ATTACHED TO AN INTRAUTERINE CANNULA, SEPARATED FROM THE CANNULA DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHEN CANNULA WITH ACORN CANNULA, INTRAUTERINE LKF RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8378.00 *
    2 COHEN CANNULA WITH ACORN CERVICAL CONE LKF RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8378.91 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES