BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3308473 · Received August 26, 2013

    Report

    Report Number
    2955842-2013-03206
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. REMOTE FE VERIFICATION OF INSTRUMENT PASSED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE RECOGNITION ISSUE. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE .080 - .425 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) 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; TUBE ABRASIONS WITH MATERIAL REMOVED ,FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SYSTEM WOULD NOT RECOGNIZE THE INSTRUMENT. THE INSTRUMENT WAS NOT USED IN THE CASE. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416982 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10120802 204

    Patients

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