BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5983007

    MDR report key: 5983007 · Received September 28, 2016

    Report

    Report Number
    5983007
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 4, 2016
    Report Date
    September 16, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON NOTICED FRACTURES AT THE TIP ON THE 12 FRENCH AIRSEAL TROCAR DURING THE ROBOTIC MYOMECTOMY. TWO LARGER PIECES AT THE TIP WERE REMOVED FROM THE TROCAR AND REMOVED FROM THE PATIENT PRIOR TO REINSERTION OF THE OBTURATOR AND REMOVAL OF THE 12 FRENCH TROCAR. THE TROCAR WAS EXAMINED BY THE SURGEON AND WAS SAVED.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR