BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE 5MM X 33CM, DISP FIXED

    MDR report key: 5033047 · Received August 26, 2015

    Report

    Report Number
    1423537-2015-00061
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 26, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS RECEIVED AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. UNFORTUNATELY THE SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, BUT A LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED 0000763574 (MANUFACTURED IN MARCH 2015) WAS REVIEWED. THIS INVESTIGATION DETERMINED THAT ALL PRODUCTS WERE MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE FOUND RELATED TO THE REPORTED ISSUE. WITHOUT THE SAMPLE AND MORE DETAILS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE ISSUE REPORTED. BASED ON THE INVESTIGATION PERFORMED WITH NO ROOT CAUSE ESTABLISHED, NO CORRECTIVE ACTION WAS DETERMINED. IF THE SAMPLE IS RECEIVED AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE SUCTION IRRIGATOR MALFUNCTIONED DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). SUCTION IRRIGATOR WOULD NOT STOP SUCTIONING AFTER SUCTION BUTTON WAS RELEASED AND CAUSED A LOSS IN CO2 IN THE ABDOMEN. MALFUNCTIONING SUCTION IRRIGATOR REMOVED FROM THE FIELD AND REPLACED WITH NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566465 PROBE 5MM X 33CM, DISP FIXED TRUMPET VALVE GBX CARDINAL HEALTH ASU1200 0000763574

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR