BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1175323 · Received July 3, 2008

    Report

    Report Number
    2020550-2008-00015
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 1, 2008
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTS THAT ALLEGEDLY DURING HYSTEROSCOPY PROCEDURE UNIT DID NOT MEASURE OUTFLOW BUT REGISTERED EVERYTHING AS DEFICIT. NURSE MONITORED INFLOW/OUTFLOW VISUALLY. IT MATCHED UP UNTIL END OF CASE WHEN SHE MEASURED OUTFLOW CONTAINERS AGAINST INFLOW BAGS AND FOUND AN 1800CC DEFICIT. AFTER PROCEDURE, PT CONDITION MONITORED. PT DID NOT EXPERIENCE FLUID OVERLOAD. PROCEDURE COMPLETED; PT CONDITION GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ EQUIMAT - FLUID MEASUREMENT DEVICE FPK KARL STORZ GMBH & CO. KG 20302020-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other