BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PADDLE RETRACT 12MM INSTRUMENT

    MDR report key: 1920738 · Received December 6, 2010

    Report

    Report Number
    2647580-2010-00944
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GAD
    PMA / PMN Number
    K914190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DEVICE WAS DEFECTIVE; THE MATERIAL AROUND THE SUPPORT CAME LOOSE. NOTHING FELL INTO THE PT'S CAVITY AND OPERATIVE TIME WAS NOT EXTENDED BY MORE THAN THIRTY MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PADDLE RETRACT 12MM INSTRUMENT DISPOSABLE SURGICAL ACCESSORY GAD USSC PUERTO RICO P0D0690

    Patients

    Seq Age Sex Outcome Treatment
    1