BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SRI SURGICAL

    MDR report key: 1696441 · Received May 14, 2010

    Report

    Report Number
    MW5016006
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 14, 2010
    Manufacturer
    SRI SURGICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN DISCONNECTING THE INSUFFLATION TAP FROM THE SUBUMBILICAL TROCAR, THERE WAS A FRACTURE OF SUBUMBILICAL TROCAR EXTERNAL TO THE ABDOMINAL CAVITY, SEVERAL CENTIMETERS ABOVE THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SRI SURGICAL LAP CHOLE INSTRUMENTS - SUBUMBILICAL TROCAR GCJ SRI SURGICAL 120711H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR