BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3778616 · Received April 29, 2014

    Report

    Report Number
    2955842-2014-02671
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 3, 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. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A DERAILED GRIP CABLE AT THE DISTAL IDLER PULLEY. GRIPS CAN STILL OPEN AND CLOSE, BUT MOVEMENT MAY NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY CONTRIBUTE TO DERAILMENT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. IN ADDITION, THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE ADDITIONAL FINDING OF THE MAIN TUBE MATERIAL REMOVAL DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT CAN NOT MAKE THE DESIRED MOVEMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257042 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11130325 644

    Patients

    Seq Age Sex Outcome Treatment
    1