BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 1250842 · Received November 25, 2008

    Report

    Report Number
    2647580-2008-00664
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    November 19, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GDI
    PMA / PMN Number
    K903205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE GRASPER JAW BROKE AND A PORTION FELL INTO THE PATIENT CAVITY, BUT WAS REMOVED. THERE WAS NO FURTHER REPORT OF COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO DISSECT 5MM INSTRUMENT ENDOSCOPIC HAND INSTRUMENT GDI PONCE-USS P8H0044

    Patients

    Seq Age Sex Outcome Treatment
    1