BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUDAL ELEVATOR

    MDR report key: 1993177 · Received January 28, 2011

    Report

    Report Number
    1993177
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    KARL STORZ
    Product Code
    KAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    DURING THE BEGINNING OF THE APPROACH FOR THE TRANSSPHENODAL SURGERY, THE DOCTOR NOTED THAT A CAUDAL ELEVATOR BROKE APART INSIDE THE NOSE. THIS RESULTED IN A PIECE OF THE ELEVATOR REMAINING INSIDE THE NOSE. THE PIECE WAS RETRIEVED BY THE SURGEON WITHIN A FEW MINUTES. THE PIECES APPEAR TO FIT TOGETHER WITHOUT ANY MISSING PARTS. AN X-RAY WAS TAKEN TO CHECK FOR ANY REMAINING PARTS. THE X-RAY WAS CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUDAL ELEVATOR ELEVATOR, ENT KAD KARL STORZ N4660 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR