BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIPORT PLUS 5MM-11MM TROCAR

    MDR report key: 1014034 · Received March 14, 2008

    Report

    Report Number
    2647580-2008-00147
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K061095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO THE REPORT: THERE WAS NO PATIENT CONTACT. THE BLADE SEEMED TO STAY OUT AFTER THE OBTURATOR WAS SLID IN THE TROCAR AND FIRED. IT WAS VERY DIFFICULT TO PLACE THE OBTURATOR IN THE TROCAR. WHEN REMOVED AND FIRED THE BLADE GOES IN AND OUT. OPENED A NEW DEVICE WITH A DIFFERENT LOT NUMBER TO PROCEED WITH THE CASE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIPORT PLUS 5MM-11MM TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7K0854

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK