BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3843928 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03374
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 7, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM AND THE INSTRUMENT PASSED ENGAGEMENT AND RECOGNITION TESTING. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. FUNCTIONAL PERFORMANCE TESTING DID NOT FIND ANY ISSUES. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE PITCH DOWN CABLE WAS FOUND TO BE FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST APPROXIMATELY .087. THE GRIPS STILL OPENED AND CLOSED WITH NO ISSUES. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH CABLE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE PROGRASP FORCEPS INSTRUMENT WOULD NOT CLOSE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321542 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10

    Patients

    Seq Age Sex Outcome Treatment
    1