BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 511158 · Received February 5, 2004

    Report

    Report Number
    2020550-2004-00002
    Event Type
    Injury
    Date Received
    February 5, 2004
    Date of Event
    January 12, 2004
    Report Date
    February 4, 2004
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    KQT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TURP PROCEDURE, A KARL STORZ CONTINUOUS FLOW PUMP WAS ALLEGEDLY USED. THE TUBING WAS CONNECTED INCORRECTLY AND THE PT'S BLADDER WAS RUPTURED. PT EXPERIENCED PNEUMOPERITONEUM, PNEUMOTHORAX AND CARDIAC ARREST. PT WAS RESUSCITATED AND LAPAROTOMY PERFORMED AND BLADDER REPAIRED. PT IS DOING WELL POST-OP AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CONTINUOUS FLOW PUMP KQT KARL STORZ ENDOVISION 27224P *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R