BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 651000 · Received December 9, 2005

    Report

    Report Number
    1056128-2005-00005
    Event Type
    Injury
    Date Received
    December 9, 2005
    Date of Event
    November 10, 2005
    Report Date
    November 11, 2005
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPARASCOPIC SURGERY, THE TIP OF AN OPTICAL TROCAR DETACHED FROM THE DEVICE INSIDE THE PATIENT. THE SURGEON PALPATED AND XRAYED THE ABDOMEN IN AN UNSUCCESSFUL ATTEMPT AT LOCATING THE TIP. THE PATIENT HAS REPORTED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA LAPROSCOPIC TROCAR GCJ VANGUARD MEDICAL CONCEPTS, INC. 35NLT 82482

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization