BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3971783 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04650
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 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

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. THE GRIP CABLES WERE DERAILED AT THE DISTAL IDLER PULLEYS WHICH MAY CAUSE MOTION TO BE NON-INTUITIVE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS /ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT. THE REPORTED CUSTOMER FAILURE MODE DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT THIS FAILURE MODE DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT. RECURRENCE OF THE ALLEGED FAILURE MODE IS NOT EXPECTED TO BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. HOWEVER, THE LIGHT MATERIAL REMOVAL FROM THE SCRATCHES ON THE MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATIONS COULD 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 PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT DID NOT RESPOND TO THE MOVEMENTS OF THE MASTER TOOL MANIPULATOR (MTM). THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). IT WAS REPORTED THAT THERE WERE INTERMITTENT ISSUES WITH THE OPENING AND CLOSING OF THE INSTRUMENT. THE SURGICAL STAFF MOVED THE INSTRUMENT TO A DIFFERENT ARM AND THE ISSUE PERSISTED. THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY OR ADVERSE OUTCOME TO A PATIENT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448597 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10131008 842

    Patients

    Seq Age Sex Outcome Treatment
    1