BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERPRT PLUS V2 5MM-12MM TRC

    MDR report key: 1250831 · Received November 25, 2008

    Report

    Report Number
    2647580-2008-00660
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 30, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K952977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: WHILE USING VERSAPORT DURING A DA VINCI CASE, A PIECE OF THE PORT BROKE OFF, WHILE THE PORT WAS INSIDE THE PATIENT. THE PIECE THAT BROKE OFF INSIDE OF THE PATIENT WAS RETRIEVED BY THE PHYSICIAN. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERPRT PLUS V2 5MM-12MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8B0201

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR