BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3193572 · Received June 14, 2013

    Report

    Report Number
    9610617-2013-00024
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K945380
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORD WAS EVALUATED UPON RETURN. THE PART OF THE CORD THAT ATTACHES TO THE INSTRUMENT HAS SEPARATED FROM THE REST OF THE CORD AND THERE ARE SIGNS OF CHARRING AT THE POINT OF BREAKAGE. IT IS POSSIBLE DAMAGE WAS DUE TO WEAR OF LONG USE. OUR IFU RECOMMENDS SWAPPING THESE CORDS OUT VERY 3 MONTHS IF USED 2-3 TIMES A WEEK. THE HOSPITAL HAS HAD THE CORD FOR 2 YEARS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272337 KARL STORZ HIGH FREQUENCY CORD GEI KARL STORZ GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1