BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3127750 · Received May 9, 2013

    Report

    Report Number
    1221826-2013-00020
    Event Type
    Other
    Date Received
    May 9, 2013
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFS
    PMA / PMN Number
    K931018
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT CABLE WAS EVALUATED. IT HAS A MANUFACTURE DATE OF 2004 AND HAS BEEN IN USE FOR APPROXIMATELY 8 YEARS. THE CABLE SHOWS SIGNS OF CONSIDERABLE WEAR AND HAS BEEN SERVICED BY A THIRD PARTY. THE COLLAR ON THE SCOPE CONNECTION END HAS NUMEROUS NICKS AND SECTIONS OF THE GROOVES ON THE SURFACE ARE PARTIALLY FLATTENED. THE COLLAR HAS EXCESSIVE PLAY; IT'S AFFIXED WITH WHAT APPEARS TO BE A SNAP RING INSTEAD OF AN ORIGINAL SLOTTED NUT. THE STRAIN RELIEFS ARE NOT ORIGINAL TO THE CABLE. THE 495G ADAPTOR WAS EVALUATED WITH THE CABLE. THE THREADS WERE FOUND TO BE WORN CAUSING A LOOSE CONNECTION BETWEEN THE LIGHT CABLE AND ADAPTOR.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205064 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOVISION

    Patients

    Seq Age Sex Outcome Treatment
    1