BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM SH W/ FIXATION

    MDR report key: 1993600 · Received January 24, 2011

    Report

    Report Number
    1219930-2011-00048
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 4, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: UPON INTRODUCTION OF THE VERSAPORT BLADELESS TROCAR/CANNULA ASSEMBLY INTO THE PT, PART OF THE BLUE PROTECTIVE SHIELD AND THE WHITE DILATING FIN BROKE OFF INSIDE THE PT. NO PT INJURY REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 5MM SH W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL U8M99

    Patients

    Seq Age Sex Outcome Treatment
    1