BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 FIXATION CANNULA 12MM

    MDR report key: 1850059 · Received September 28, 2010

    Report

    Report Number
    2647580-2010-00791
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 30, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: DURING THE CASE, IT WAS NOTICED, THE PART THAT COVERS THE KNIFE CAME OFF, SO THE KNIFE BLADE WAS EXPOSED. THERE WAS NO ADDITIONAL BLEEDING. NOTHING FELL INTO THE PT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INJURY WAS REPORTED. NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 FIXATION CANNULA 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1