BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT PLUS V2 5MM-11MM TROCAR

    MDR report key: 901895 · Received August 20, 2007

    Report

    Report Number
    2647580-2007-00366
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 27, 2007
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 08/16/2007.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK; PT GENDER:UNK. ACCORDING TO THE REPORTER, DURING THE UTILIZATION OF THE TROCAR, A METALLIC PART DETACHED AND WAS FOUND ON THE STOMACH OF THE PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT PLUS V2 5MM-11MM TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7C0661

    Patients

    Seq Age Sex Outcome Treatment
    1 YR