BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ CAMERA

    MDR report key: 6538101 · Received April 28, 2017

    Report

    Report Number
    MW5069483
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    December 23, 2016
    Report Date
    April 19, 2017
    Manufacturer
    KARL STORZ
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT FOR LAPAROSCOPIC REPAIR OF A RIGHT INGUINAL HERNIA. DURING THE PROCEDURE DARK SMOKE WAS NOTED FROM THE CAMERA UNIT OF THE LAPAROSCOPY TOWER. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313502 KARL STORZ CAMERA CAMERA FXM KARL STORZ 212020

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR