BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 RT 5MM OBTURATOR W/5MM SEAL

    MDR report key: 1210043 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00597
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    PMA / PMN Number
    K963115
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: OOPHROCYSTECTOMY ACCORDING TO THE REPORTER: AFTER INSERTING INSTRUMENT AND WHEN HE REMOVED THE OBTURATOR FROM THE CAVITY, THE COVER OF KNIFE DISENGAGED. IT WAS CAUGHT ON INSIDE OF CANNULA, SO NOTHING FELL INTO THE CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER. NO TISSUE DAMAGE. NO BLEEDING. NOTHING FELL INTO THE CAVITY. EXTENDED OR TIME: UNK. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 RT 5MM OBTURATOR W/5MM SEAL DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE-USS P8G0103

    Patients

    Seq Age Sex Outcome Treatment
    1