BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3041563 · Received April 8, 2013

    Report

    Report Number
    2955842-2013-01153
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    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 ONE GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS. THE BROKEN SEGMENT STUCK OUT APPROXIMATELY .4760 AT THE WRIST. THE IDLER PULLEYS ON THE DISTAL END SPUN FREELY BUT DID EXHIBIT SOME DAMAGE. ONE PULLEY HAD SEVERAL INDENTATIONS ALONG THE EDGES AND THE OTHER HAD WEAR MARKS FROM THE GRIP CABLE RUBBING AGAINST IT. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ENGINEERING ALSO FOUND A DAMAGED BLADE AND A DEEP SCRATCH MARK ON THE MAIN TUBE. THE INSTRUMENT BLADE APPEARED TO HAVE INDENTATIONS ALONG THE EDGES OF ONE BLADE. THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THAT DAMAGE TO THE BLADE WAS LIKELY DUE TO MISHANDLING. 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 DURING REPROCESSING THE DA VINCI SI SURGICAL MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS NOTED TO HAVE A WIRE STICKING OUT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144138 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10101110 186

    Patients

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