BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3982043 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04740
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CLOSE CABLE WAS DERAILED FROM THE DISTAL IDLER PULLEYS. THE CABLE WAS SEATED ON THE OUTERMOST PULLEY. YAW MOTION WAS NON-INTUITIVE AS A RESULT. THE OTHER CABLES AT THE WRIST WERE INTACT AND UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE APPROXIMATELY .111 - .167 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE DAMAGE TO THE INSTRUMENT FOUND DURING FAILURE ANALYSIS INVESTIGATION DOES NOT CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE MAIN TUBE WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT WAS STIFF AND IT WOULDN'T OPEN. THERE WAS NO REPORT OF FRAGMENTS FALLING 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
    457540 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10140228 688

    Patients

    Seq Age Sex Outcome Treatment
    1