BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3913679 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04076
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE GRIP CABLE WAS DERAILED AT THE DISTAL CLEVIS HUB. THE HUB DID NOT EXHIBIT ANY WEAR. THE YAW MOTION WAS NON-INTUITIVE AS A RESULT. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE 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 WIRES WAS NOTED TO BE BROKEN AND THE INSTRUMENT WOULD NOT OPEN OR CLOSE; THE CABLE WAS NOTED OFF THE WHEEL TRACK 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
    391204 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140225 810

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR