BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3243754 · Received July 23, 2013

    Report

    Report Number
    2955842-2013-02697
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 14, 2013
    Report Date
    July 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT; THE INSTRUMENT CABLE WAS NOT BROKEN. ENGINEERING FOUND UPON VISUAL INSPECTION THAT THE PITCH CABLES WERE LOOSE, BUT NOT VISIBLY BROKEN AT THE WRIST. THE PITCH MOTION WAS NOT INTUITIVE DUE TO LOOSE CABLES. ADDITIONAL OBSERVATIONS FOUND BY ENGINEERING NOT REPORTED BY SITE WAS THAT THE INSTRUMENT PITCH CABLES WAS DERAILED FROM THE BACK IDLER PULLEYS IN THE HOUSING. THE CABLE WAS WEDGED BETWEEN TWO PULLEYS AND HAD LOST TENSION. THE CLAMPING PULLEY SCREWS WERE STILL TIGHT. ENGINEERING ALSO FOUND THE MAIN TUBE HAD VARIOUS SCRATCH MARKS AT THE DISTAL END SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .050 - .185 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. THE INSTRUMENT HAS NOT YET BEEN EVALUATED; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE INSTRUMENT HAS BEEN EVALUATED, OR IF ADDITIONAL INFORMATION IS RECEIVED. 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 S SURGICAL PROCEDURE THE PROGRASP FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. NO MISSING OR FALLEN PIECES WERE 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
    342568 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130403 253

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM, INSTRUMENTS & ACCESSORIES