BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3591793 · Received January 24, 2014

    Report

    Report Number
    2955842-2014-00465
    Event Type
    Other
    Date Received
    January 24, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FSE REPAIRED THE DA VINCI SURGICAL SYSTEM BY REMOVING AN UNIDENTIFIED METAL OBJECT THAT WAS FOUND TO BE JAMMED UNDER THE ECM FOOT PEDAL. THE UNIDENTIFIED METAL OBJECT IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI MYOMECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING ISSUES WITH CONTROLLING THE PSM'S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI MYOMECTOMY PROCEDURE, THE SURGEON BEGAN TO HAVE TROUBLE CONTROLLING THE PATIENT SIDE MANIPULATORS (PSM) WITH THE MASTER TOOL MANIPULATORS (MTM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE MTM 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). DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI MYOMECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE FOUND A PIECE OF METAL JAMMED IN THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) FOOT PEDAL THAT WAS NOT ALLOWING IT TO FULLY DISENGAGE. ACCORDING TO THE DA VINCI SI USER MANUAL, PRESSING THE CAMERA PEDAL TAKES ALL INSTRUMENTS OUT OF FOLLOWING... WHEN YOU RELEASE THE CAMERA PEDAL, THE MASTERS RESUME CONTROL OF THE INSTRUMENTS. AFTER THE FSE REMOVED THE METAL OBJECT, PROPER ECM FOOT PEDAL OPERATION AND CONTROL OF THE PSM'S WERE RESTORED. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM TO MANUFACTURER SPECIFICATIONS. ON (B)(4) 2014, ISI CONTACTED THE FSE. THE FSE STATED THAT WITHIN 5 MINUTES OF EVALUATING THE SURGEON SIDE CONSOLE (SSC), HE NOTICED THAT THE ECM PEDAL WAS PRESSED DOWN AND STUCK. IMMEDIATELY AFTER NOTICING THAT THE PEDAL WAS STUCK, HE FOUND A 3 MM X 2 MM UNIDENTIFIED METAL OBJECT SHAPED LIKE A 'U' JAMMED TOWARDS THE FRONT OF THE ECM PEDAL BETWEEN THE RUBBER PORTION OF THE PEDAL AND PLASTIC PORTION OF THE SSC. HE WAS ABLE TO REMOVE THE METAL OBJECT WITH TWEEZERS. HE WAS UNABLE TO IDENTIFY WHAT THE METAL OBJECT WAS OR WHERE IT CAME FROM. HE DID NOT SEE ANY BROKEN FRAGMENTS ON THE SSC. ON (B)(4) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGEON BEGAN TO EXPERIENCE ISSUES WITH CONTROLLING THE PSM'S MID-PROCEDURE. DUE TO THE REPORTED ISSUE WITH CONTROLLING THE PSM'S, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. ACCORDING TO THE ROBOTICS COORDINATOR, THE OPEN SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTED COMPLICATIONS. THE ROBOTICS COORDINATOR WAS UNABLE TO IDENTIFY THE METAL OBJECT THAT WAS FOUND BY THE FSE OR WHERE IT CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56793 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other