BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 1744212 · Received June 28, 2007

    Report

    Report Number
    2647580-2010-00586
    Event Type
    Malfunction
    Date Received
    June 28, 2007
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    PMA / PMN Number
    K904578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(6) 2010.

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THE SURGEON TRIED TO CLOSE THE BAG MANUFACTURED BY JSS, YET THE TIP OF THE DEVICE WAS BROKEN. THE FALLEN PIECE COULD BE RETRIEVED FROM THE PT. THE STAFF USED ANOTHER DEVICE. THERE WAS NO BLEEDING OR TISSUE DAMAGE. THE PROCEDURE WAS NOT EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO DISSECT 5MM INSTRUMENT DISPOSABLE SURGICAL ACCESSORY GET USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1