BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 3243954 · Received July 23, 2013

    Report

    Report Number
    2955842-2013-02703
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    GCJ
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT WAS BROKEN AT THE PROXIMAL CLEVIS TO THE MAIN TUBE INTERFACE. THE CLEVIS WAS DISLODGED FROM THE MAIN TUBE AS A RESULT, BUT WAS NOT BROKEN. THERE WERE LIKELY MISSING PIECES FROM THE BREAKAGE. THE BREAKAGE WAS LIKELY DUE TO OVERLOADING AT THE TIP. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE CADIERE FORCEPS INSTRUMENT WAS OBSERVED TO BE SEPARATED AT THE TIP. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342162 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL,INC. 428055-12 S10120621 189

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES