BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE STERILIZATION

    MDR report key: 2192653 · Received August 2, 2011

    Report

    Report Number
    MW5021589
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOCTOR ATTEMPTED TO DEPLOY ESSURE COIL INTO THE TUBE ON LEFT SIDE. DOCTOR STATED THE SHEATH WAS TORN AS HE STARTED TO DEPLOY THE COIL CAUSING THE COIL NOT TO GO IN PROPERLY. HE THEN TRIED TO PULL OUT THE ESSURE COIL AND IT BROKE OFF 3 DIFFERENT TIMES. THREE PIECES OF THE COIL WERE TAKEN OUT LEAVING SOME COIL STILL IN THE TUBE. A NEW ESSURE WAS ATTEMPTED ON THE LEFT SIDE AND THEY WERE NOT ABLE TO INSERT IT INTO THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE STERILIZATION STERILIZATION COIL HHS CONCEPTUS ESS305 825629

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR