BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3162235 · Received April 29, 2013

    Report

    Report Number
    2020550-2013-00015
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FWF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE BEGINNING OF A LAPAROSCOPIC COLON RESECTION PROCEDURE ON A FEMALE PATIENT, THE PICTURE STARTED FLICKERING; THEY ADJUSTED THE CABLE AND THE BLINKING STOPPED. IT STARTED BLINKING AGAIN SO THEY GOT ANOTHER CAMERA; THERE WAS INTERMITTENT BLINKING AND WHEN THE DOCTOR WAS READY TO DO THE CASE, THE PICTURE CAME BACK ON, THEN WENT BLACK AGAIN. AT THAT POINT THE DOCTOR DECIDED TO OPEN THE PATIENT. PROCEDURE WAS COMPLETED; PATIENT IS REPORTED TO BE DOING VERY WELL POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184658 KARL STORZ NONE FWF KARL STORZ IMAGING 22201011U102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other