BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3407147 · Received October 11, 2013

    Report

    Report Number
    2955842-2013-04387
    Event Type
    Other
    Date Received
    October 11, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 13, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE PERFORMED A FIELD EVALUATION AT THE SITE ON (B)(4) 2013 AND WAS UNABLE TO REPRODUCE THE REPORTED ENDOSCOPE FOGGINESS ISSUE. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. TOWARDS THE END OF THE SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ERROR CODE 48224 INDICATING THAT THE CAMERA HEAD BUTTON WAS STUCK. ACCORDING TO THE SYSTEM LOG, THE SURGICAL STAFF WAS ABLE TO IMMEDIATELY OVERRIDE THE FAULT. NO OTHER SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A BLURRY IMAGE ISSUE AND ENDOSCOPE FOGGINESS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PANCREATECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE ENDOSCOPES WERE FOGGING AND THE IMAGES APPEARED BLURRY. THE SURGICAL STAFF TRIED 3 DIFFERENT ENDOSCOPES AND ALL WERE REPORTEDLY FOGGING. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGICAL STAFF PERFORMED ENDOSCOPE ALIGNMENTS AND CHECKED FOR ANY FOCUSING ISSUES. THROUGH TROUBLESHOOTING, THE SURGICAL STAFF WAS UNABLE TO GET THE ENDOSCOPES FROM EXHIBITING A BLURRY IMAGE. DUE TO THE REPORTED ENDOSCOPE ISSUES AND BLURRY VISION, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES. ON THE SAME DAY ((B)(6) 2013) THE ALLEGED ENDOSCOPE ISSUES OCCURRED, AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THROUGH TROUBLESHOOTING, THE FSE WAS UNABLE TO REPLICATE THE ALLEGED ENDOSCOPE FOGGING ISSUE. THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(6) 2013, THE FSE FOLLOWED UP WITH THE SITE AND VERIFIED THAT THERE WERE NO REPORTED RECURRENCES OF THE ENDOSCOPE FOGGING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522279 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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