BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 BLADELESS OPT 12

    MDR report key: 3872494 · Received May 27, 2014

    Report

    Report Number
    1219930-2014-00401
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: PRODUCT SEAL CAME OFF OF THE PRODUCT AND FELL INTO THE PT. A DEVICE FRAGMENT FELL IN THE PT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311748 VERSAPORT V2 BLADELESS OPT 12 DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL N3M0027UX

    Patients

    Seq Age Sex Outcome Treatment
    1