BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITIVE

    MDR report key: 686286 · Received February 20, 2006

    Report

    Report Number
    MW1038077
    Event Type
    Injury
    Date Received
    February 20, 2006
    Date of Event
    February 3, 2006
    Report Date
    February 20, 2006
    Manufacturer
    MICROTEK MEDICAL, INC
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A LAPAROSCOPIC ROBOTIC ASSISTED HYSTERECTOMY. DURING THE PROCEDURE, THE INTUITIVE HARMONIC CURVED SHEARS BROKE APART INSIDE THE PT. THE PHYSICIAN WAS ABLE TO GO AFTER AND RETRIEVE THE TOP CURVED PART OF SHEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTUITIVE HARMONIC CURVED SHEARS INSERT --- MICROTEK MEDICAL, INC * C5269

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability