BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 978641 · Received May 11, 2007

    Report

    Report Number
    2020550-2007-00010
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    April 4, 2007
    Report Date
    May 10, 2007
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HKK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS MDR IS BASED ON PRELIMINARY INFO REC'D, HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. DURING A LAP SIGMOID RESECTION, THE SURGEON DELAYED THE CASE DUE TO THE "GRAININESS" ON THE MONITOR. THE OR MGR SWAPPED OUT THE CAMERA CCU, CAMERA HEAD, AND TELESCOPE, BUT THE COMPLAINT WAS NOT RESOLVED AND THE PICTURE REMAINED PIXELATED. THE DR MADE THE DECISION TO ABANDON THE LAPAROSCOPY PROCEDURE AND PERFORM OPEN SURGERY. THE HOSP REPORTED THAT THERE WAS NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ HOPKINS II TELESCOPE HKK KARL STORZ GMBH & CO. KG 260006BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other