BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ TELESCOPE

    MDR report key: 298319 · Received September 27, 2000

    Report

    Report Number
    2020550-2000-00020
    Event Type
    Injury
    Date Received
    September 27, 2000
    Date of Event
    July 20, 2000
    Report Date
    September 20, 2000
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, TELESCOPE END SPONTANEOUSLY OPENED AND ROD LENSES SPILLED INTO ABDOMEN. ALL BUT ONE ROD WERE RETRIEVED DURING INITIAL SURGERY. PT WAS RETURNED TO OPERATING ROOM FOR REMOVAL OF FINAL ROD ON SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ TELESCOPE TELESCOPE GCJ KARL STORZ GMBH & CO. 26006AA *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention