BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABDOMINAL TROCAR

    MDR report key: 33696 · Received June 24, 1996

    Report

    Report Number
    MW4001359
    Event Type
    Malfunction
    Date Received
    June 24, 1996
    Report Date
    April 24, 1996
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON OF THE BLUNT TIP TROCAR RUPTURED AND WAS DISCOVERED AFTER IT WAS INSERTED INTO PT'S ABDOMEN. THE TROCAR WAS REMOVED AND REPLACED. IT WAS EXAMINED FOR POSSIBLE CAUSES AS WELL AS POTENTIAL MISSING FRAGMENTS, WHICH WAS NOT ABLE TO BE DETERMINED. THE SURGEONS LOOKED AROUND THE ABDOMINAL CAVITY, CONNECTED NEW TROCAR TO SEARCH FOR POSSIBLE FRAGMENTS, AND NONE WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABDOMINAL TROCAR ABDOMINAL TROCAR GCJ ORIGIN MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA