BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERPRT PLUS V2 5MM - 11MM TRC

    MDR report key: 1833520 · Received September 8, 2010

    Report

    Report Number
    2647580-2010-00753
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: A PIECE OF THE BLUE PLASTIC THAT COVERS THE BLADE FELL OFF WHEN INTRODUCING THE TROCAR. THERE WAS NO BLOOD LOSS GREATER THAN 250CC. THERE WAS A DELAY OF 15 MINUTES. ANOTHER TROCAR WAS USED TO FINISH THE PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERPRT PLUS V2 5MM - 11MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO 90C0105

    Patients

    Seq Age Sex Outcome Treatment
    1