BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3190830 · Received June 26, 2013

    Report

    Report Number
    2955842-2013-02298
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 31, 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 CLOSE CABLE WAS BROKEN AT THE FORCE AMP PULLEY. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. ENGINEERING ALSO FOUND MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .110 - .175 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY CAUSED BY 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. 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 PROSTATECTOMY PROCEDURE THE PROGRASP FORCEPS INSTRUMENT WAS NOTED TO HAVE A BROKEN CABLE AT THE DISTAL END. 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
    290919 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11130412 546

    Patients

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