BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHEN INTRAUTERINE PROBE

    MDR report key: 3212341 · Received July 2, 2013

    Report

    Report Number
    2523190-2013-00044
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HCZ
    PMA / PMN Number
    K060233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    MEDWATCH #(B)(4) WAS RECEIVED ON (B)(6) 2013 STATING THAT; PATIENT WAS DISCHARGED HOME AFTER AN OUTPATIENT LAPAROSCOPIC/GYNECOLOGICAL PROCEDURE. PATIENT WAS TRYING TO VOID WHEN A "LARGE METAL OBJECT" CAME OUT OF HER VAGINA. SHE REPORTED THIS TO HER SURGEON WHO IDENTIFIED THE OBJECT AS THE CERVICAL CONE PORTION OF A COHEN ACORN CANNULA. THE CONE WAS INADVERTENTLY LEFT INSIDE THE VAGINA UPON REMOVAL OF THE CANNULA. THE CERVICAL CONE PORTION OF THE DEVICE SCREWS ONTO THE DISTAL END OF THE CANNULA AND WAS ASSUMED TO BE LOOSE UPON REMOVAL. NEITHER SURGEON NOR THE SURGICAL TECH NOTICED IT WAS MISSING UPON REMOVAL. ON (B)(6) 2013 CUSTOMER REPORTS THE DEVICE WAS EXPELLED THE SAME DAY AS SURGERY, NO HARM DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303064 COHEN INTRAUTERINE PROBE NA HCZ INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR