BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISPRT PLUS 5MM-11MM TRC

    MDR report key: 3853778 · Received May 30, 2014

    Report

    Report Number
    9612501-2014-00163
    Event Type
    Other
    Date Received
    May 30, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K935086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: SURGEON NOTICED BLACK FLECKS IN TROCAR AND IS WORRIED THEY WERE INJECTED INTO PATIENT WHEN BLADE IS FIRED. THIS HAS OCCURRED TWICE AT THIS FACILITY WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319983 VISPRT PLUS 5MM-11MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J3L0905X

    Patients

    Seq Age Sex Outcome Treatment
    1