BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSUFFLATOR

    MDR report key: 23150 · Received June 12, 1995

    Report

    Report Number
    2020550-1995-00021
    Event Type
    Other
    Date Received
    June 12, 1995
    Date of Event
    June 5, 1995
    Report Date
    June 8, 1995
    Manufacturer
    KARL STORZ ENDIVISION
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A GYNECOLOGICAL LASER ABLATION PROCEDURE, THE PT HAD CREPITUS AND RECEIVED A COLLAPSED LUNG. ALTHOUGH A CO'S INSUFFLATOR WAS USING DURING THE PROCEDURE, IT WAS NOT CLEAR IF IT HAD CONTRIBUTED TO ANY OF THE COMPLICATIONS. PT'S CURRENT CONDITION IS NOT KNOWN BY THE CO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATOR INSUFFLATOR FCX KARL STORZ ENDIVISION 26012C

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other