BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 4220729 · Received November 3, 2014

    Report

    Report Number
    2647580-2014-00932
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THE TROCAR SLEEVE ANCHOR TABS FRAGMENTED ON INSERTION INTO THE PATIENTS TISSUE. DEVICE FRAGMENTS FELL INTO THE PATIENT AND THE INCISION HAD TO BE EXTENDED TO REMOVE THE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701822 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC 24055 P0L0790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other