BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3241754 · Received July 22, 2013

    Report

    Report Number
    2955842-2013-02688
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    June 25, 2013
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND A LOOSE PITCH CABLE. BASED ON THIS, THE COMPLAINT WAS CONFIRMED. INTUITIVE MOTION WAS NOT FUNCTIONING DUE TO A LOOSE PITCH CABLE FOUND AT THE DISTAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS. THE HOUSING WAS REMOVED AND ENGINEERING FOUND THE PITCH CABLE WAS LOOSE AT THE CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. THE PITCH CABLE WAS ALSO FOUND TO BE FRAYED. THE FRAYED SEGMENT STUCK OUT AT THE WRIST. ENGINEERING ALSO FOUND INSULATION DAMAGE ON THE DISTAL END OF THE MAIN TUBE AT SEVERAL AREAS. MATERIAL WAS MISSING. THE SURFACE OF THE MAIN TUBE APPEARED TO BE SCRAPED OFF. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE THE PROGRASP FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN TIP. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    341580 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M20120220 333

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES