BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3289502 · Received August 9, 2013

    Report

    Report Number
    2955842-2013-03015
    Event Type
    Other
    Date Received
    August 9, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED BY INTUITIVE SURGICAL, INC (ISI) FIELD SERVICE ENGINEERING WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SURGEON. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER EXPERIENCING NON-INTUITIVE MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION WHILE MANIPULATING THE INSTRUMENTS INSTALLED ON THE PT SIDE MANIPULATOR (PSM) ARMS FROM THE MASTER TOOL MANIPULATORS. IT WAS ALSO REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY USING CAUTERY. THE SITE CONTACTED INTUITIVE SURGICAL, INC (ISI) FOR TROUBLESHOOTING ASSISTANCE, AFTER THE SURGEON HAD MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PT HARM WAS REPORTED. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT THERE WERE NO SYSTEM ERRORS CODES GENERATED RELATED TO THE REPORTED ISSUE. ON (B)(4) 2013 ISI CONTACTED THE NURSE MANAGER WHO INITIALLY REPORTED THIS COMPLAINT. THE NURSE MANAGER INDICATED THAT SHE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE PT WAS PLACED IN THE TRENDELENBURG POSITION AND THAT SHE OBSERVED THAT THE PORT SITE INCISIONS WERE SLIGHTLY CLOSE AND THE PSMS WERE "TOO STRAIGHT". SHE INDICATED THAT THE SURGICAL STAFF ATTEMPTED TO TROUBLESHOOT THE ISSUE, BUT WERE UNABLE TO RESOLVE THE ISSUE. THE NURSE MANAGER WAS UNABLE TO PROVIDE THE DETAILS CONCERNING THE SPECIFIC TROUBLESHOOTING TECHNIQUES THAT WERE PERFORMED TO RESOLVE THE ISSUE. ON (B)(4) 2013 ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT APPROX 20 MINUTES INTO THE DA VINCI SURGICAL PROCEDURE, HE OBSERVED THAT THE IMAGE THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV) WAS INVERTED. AFTER ACTIVATING CAUTERY ENERGY WHILE USING THE RIGHT MASTER TOOL MANIPULATOR, TISSUE ON THE LEFT SIDE WAS CAUTERIZED. THERE WAS NO INJURY TO THE PT, AS THE AFFECTED TISSUE WAS BEING CAUTERIZED AS PART OF THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THERE WERE NO ISSUES WITH PLACEMENT OF THE PORT SITE INCISION OR THE PORTION OF THE PSM DURING THE SURGICAL PROCEDURE. HE INDICATED THAT THE SURGEON SIDE CONSOLE SETTINGS WERE FOUND TO BE CORRECT AND THERE WERE NO CAMERA ISSUES THAT OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PT TOLERATED THE OPEN PROCEDURE WELL AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381598 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY NAY INTUITIVE SURGICAL, INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other ESU| ACCESSORY| DAV SI SURG. SYSTEM INSTRUMENTS