BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1359224 · Received March 24, 2009

    Report

    Report Number
    2020550-2009-00007
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DR WAS PERFORMING A LAP CHOLE PROCEDURE WHEN THE ANESTHESIOLOGIST NOTICED THE PT WAS EXPERIENCING RESPIRATORY DISTRESS. THEY CHECKED UNIT AND FOUND THE PRESSURE SETTING HAD GONE UP TO 30; UNIT DID NOT ALARM. OR PERSONNEL OPENED TROCAR VALVE FOR VENTING AND BROUGHT THE PRESSURE DOWN TO ACCEPTABLE LEVEL (15). PROCEDURE WAS COMPLETED. PT HAD EARLY ONSET OF PULMONARY EDEMA AND SHE WAS INTUBATED AND RE-OXYGENATED AND STAYED IN THE HOSP ONE DAY AFTER PROCEDURE. SHE WAS RELEASED THE FOLLOWING MORNING. PT SHOWED NO LONG TERM EFFECTS AND CONDITION IS STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ THERMOFLATOR GCJ KARL STORZ ENDOVISION 26432020-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other