BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAUTERINE CANNULA CERVICAL CONE

    MDR report key: 2000506 · Received February 1, 2011

    Report

    Report Number
    1418479-2011-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 31, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. WE EXPECT THE DEVICE TO BE AVAILABLE SHORTLY AND WILL SUBMIT A FOLLOW-UP TO FDA WITH THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC TUBAL LIGATION UNDER GENERAL ANESTHESIA. THE PATIENT WAS DISCHARGED HOME LATER THE SAME DAY. THE EVENING OF THE PROCEDURE, THE PATIENT AWOKE TO GO TO THE BATHROOM AND NOTED THAT A SMALL PLASTIC FOREIGN BODY HAD FALLEN OUT OF HER VAGINA. THE FOLLOWING DAY SHE WAS EXAMINED BY HER TREATING PHYSICIAN. IT WAS DETERMINED THAT THE RETAINED DEVICE WAS AN ACORN TIP OF A WOLF ACORN UTERINE MANIPULATOR. THERE WAS NO INJURY OR OTHER RETAINED DEVICES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAUTERINE CANNULA CERVICAL CONE INTRAUTERINE CANNULA CERVICAL CONE LKF RICHARD WOLF MEDICAL INSTRUMENTS 8378.90

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR