BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER FOR COHEN CANNULA

    MDR report key: 5704288 · Received June 7, 2016

    Report

    Report Number
    8043746-2016-00001
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    December 29, 2015
    Report Date
    June 1, 2016
    Manufacturer
    TROKAMED GMBH
    Product Code
    GCJ
    PMA / PMN Number
    K060233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ADAPTER WAS INSPECTED AND CONNECTED WITH A NEW COHEN CANNULA PER DETAILED INSTRUCTIONS FOR ASSEMBLY AND USE PROVIDED THE USER. NO DEVICE FAILURE WAS OBSERVED. THE CONNECTION CONFORMS TO SPECIFICATIONS. IT IS PRESUMED THAT INSTRUCTIONS FOR USE WERE NOT CORRECTLY OBSERVED BY USER. THE ADAPTER WAS NOT SCREWED TIGHTLY ON THE PROBE, CAME LOOSE DURING THE PROCEDURE, AND WAS FORGOTTEN INSIDE THE PATIENT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, THE UTERINE MANIPULATOR WAS REMOVED. THE ACORN CAME LOOSE FROM THE INSTRUMENT AND WAS RETAINED IN THE PATIENT'S BODY. TWO DAYS AFTER THE PROCEDURE, THE ACORN FELL OUT OF THE VAGINA. NO HARM WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357795 ADAPTER FOR COHEN CANNULA COHEN INTRAUTERINE PROBE GCJ TROKAMED GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR