BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1960975 · Received January 11, 2011

    Report

    Report Number
    MW5018963
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 29, 2010
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS DEVICE WAS DEPLOYED, IT BROKE APART. BROKEN PIECES WERE ALL RETRIEVED BY THE MD., COIL LEFT INSIDE PT'S TISSUE AS PER MANUFACTURER'S INSTRUCTIONS. PER OP REPORT; IT FELL APART INTO THREE PIECES. EACH INDIVIDUAL PIECE WAS REMOVED WITH THE GRASPER AND THE REMAINING PART THAT WAS PROTRUDING FROM THE CERVICAL OS WAS ALSO REMOVED. THE OS WAS CLOSELY INSPECTED. THERE WAS ANOTHER COIL VISIBLE INSIDE THE TUBAL OSTIUM. IT WAS APPROX 2 MM INSIDE THE OSTIUM, SO ATTEMPTS WERE NOT MADE TO RETRIEVE IT. A SECOND ESSURE WAS USED WITH NO DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE IMPLANT FOR PERMANENT STERILIZATION IN FEMALE PATIENTS HHS 685787

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR