BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3162237 · Received April 19, 2013

    Report

    Report Number
    2020550-2013-00017
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 19, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DOCTOR WAS PERFORMING A TURP WHEN THE UNIT MADE A "POPPING" SOUND AND SMOKE EMITTED FROM THE BACK; UNIT NO LONGER FUNCTIONED. DOCTOR SWITCHED TO ALTERNATIVE SETUP TO COMPLETE PROCEDURE. THIS SWITCH TOOK 45 MINUTES; PROCEDURE WAS COMPLETED AND PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169706 KARL STORZ AUTOCON ESU GEI KARL STORZ GMBH & CO. KG 20535202U125-US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other