BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 2951164 · Received February 8, 2013

    Report

    Report Number
    2955842-2013-00451
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION CONFIRMED THE ALLEGED COMPLAINT OF A LOOSE WIRE. ONE GRIP CLOSE CABLE WAS FOUND TO BE LOOSE AT THE DISTAL IDLERS. THE IDLER PULLEY WAS OBSERVED TO SPIN FREELY AND WAS NOT DAMAGED. THE CLAMPING PULLEY SCREWS WERE FOUND TO BE SECURED. THE IDLER BLOCK SHOWED NO SIGN OF DAMAGE. ENGINEERING EVALUATION ALSO FOUND SCRATCHES ON THE INSTRUMENT'S MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT THE DAMAGE MIGHT HAVE BEEN DUE TO MISHANDLING. UPON OPENING THE INSTRUMENT'S HOUSING, ENGINEERING EVALUATION ALSO FOUND CORROSION AND RESIDUE BY THE CLAMPING PULLEY. 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 MAIN TUBE SCRATCH ISSUE 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 SURGICAL STAFF REPORTED SEEING A LOOSE WIRE ON THE CADIERE FORCEPS INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT. THE REPORTER DENIED THAT THE INSTRUMENT WAS USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53589 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-06 M10120615 256

    Patients

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