BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO MINI - SHEARS 5MM INSTR.

    MDR report key: 1940540 · Received December 9, 2010

    Report

    Report Number
    2647580-2010-00956
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K914752
    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: LOBECTOMY. ACCORDING TO THE REPORTER: THE DEVICE FELT STIFF WHILE ROTICULATING. THE DEVICE WAS ROTICULATED SEVERAL TIMES AND THEN THE TIP OF THE SHAFT BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO MINI - SHEARS 5MM INSTR. DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO P8H0543

    Patients

    Seq Age Sex Outcome Treatment
    1