BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 4028978 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05121
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    February 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT'S PITCH CABLE DOWN IS LOOSE/UNRAVELING AT THE WRIST. THERE IS NO DAMAGE TO THE DISTAL CLEVIS. THE CABLE IS BECOMING UNDONE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE INSTRUMENT'S GRIP OPEN CABLE IS SEATED ON THE OUTERMOST PULLEY AND THE GRIP CLOSE CABLE IS EXPOSED ON OUTSIDE OF THE PULLEY. THE YAW MOTION IS NON-INTUITIVE AS A RESULT. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .201 - .060 IN LENGTH AND ARE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, 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 DURING REPROCESSING OF THE PROGRASP FORCEPS INSTRUMENT IT WAS OBSERVED THAT THE INSTRUMENT HAS LOOSE WIRES. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO A PATIENT AND THERE WAS NO ALLEGATION OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507543 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131107 791

    Patients

    Seq Age Sex Outcome Treatment
    1