BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3881329 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03730
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS PLACED THE INSTRUMENT ON AN IN-HOUSE SYSTEM AND IT WAS SUCCESSFULLY DRIVEN; THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION. THIS IS NOT AN ENERGY INSTRUMENT THEREFORE, FAILURE ANALYSIS WAS NOT ABLE TO REPLICATE COMPLAINT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. FAILURE ANALYSIS REMOVED THE HOUSING AND FOUND THAT ONE OF THE PITCH CABLES WAS DERAILED FROM THE CLAMPING PULLEYS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS, 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 THE PROGRASP FORCEPS INSTRUMENT WAS NOTED TO BE OVERHEATING DURING A DA VINCI SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. 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
    357022 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131107 718

    Patients

    Seq Age Sex Outcome Treatment
    1