BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 2944605 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00391
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT THAT A WIRE CAME OFF A TRACK WAS CONFIRMED. ONE GRIP CLOSE CABLE WAS FOUND TO BE DERAILED AT THE DISTAL IDLER PULLEY. THE INSTRUMENT GRIPS WERE STILL ABLE TO OPEN AND CLOSE. ENGINEERING CONCLUDED THAT THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. ENGINEERING ALSO CONCLUDED THAT POSSIBLY THE FLEET ANGLE BETWEEN THE PROXIMAL AND DISTAL PULLEYS MIGHT HAVE CONTRIBUTED TO DERAILMENT. ELECTRICAL CONTINUITY TESTING OF THE INSTRUMENT PASSED. AN ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS SCRATCHES ON THE INSTRUMENT'S MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ANOTHER FINDING NOT REPORTED BY THE SITE WAS A BENT BIPOLAR PIN. THE BOTTOM PIN WAS FOUND TO BE BENT UPWARD. ENGINEERING CONCLUDED THAT THE OBSERVED DAMAGES MIGHT HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. O 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 DURING A DA VINCI SI NEPHRECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT A WIRE CAME OFF THE TRACK ON THE TOP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48902 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120425 979

    Patients

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