BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2860203 · Received December 1, 2012

    Report

    Report Number
    1221826-2012-00045
    Event Type
    Other
    Date Received
    December 1, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 30, 2012
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION STATED THAT THERE IS NO IMAGE DUE TO MOISTURE ON THE CONDUCTOR BOARD CAUSING IMAGE FAILURE AND LOW LIGHT GUIDE TRANSMISSION. THE VIDEO ENDOSCOPE HAD BEEN CLEANED WITH THE PRESSURE CAP ON PRIOR TO THE PROCEDURE. THIS RESULTED IN MOISTURE INSIDE THE VIDEO ENDOSCOPE AND CAUSED IMAGE FAILURE. THE CONDITION OF THE SCOPE IS CONSISTENT WITH IMPROPER STERILIZATION. KARL STORZ INSTRUCTIONS FOR USE INDICATE THE PRESSURE CAP MUST BE REMOVED DURING CLEANING AND SOAKING IN DISINFECTANT SOLUTION.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A URETERAL STONE REMOVAL PROCEDURE, THERE WAS NO IMAGE WITH THE VIDEO SCOPE. THE HOSPITAL DID NOT HAVE A BACKUP SCOPE. THE CASE HAD TO BE ABORTED AND RESCHEDULED TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ VIDEO URETEROSCOPE KOG KARL STORZ ENDOVISION 11278VU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other