BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3293203 · Received August 16, 2013

    Report

    Report Number
    2955842-2013-03070
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE CAUTERY ISSUE EXPERIENCED BY THE SITE. THE FSE TESTED THE SITE'S DA VINCI SURGICAL SYSTEM AND IT WAS FOUND TO FUNCTION WITHIN SPECIFICATIONS. FUNCTIONAL TESTING OF THE SYSTEM IN CONJUNCTION WITH THE SITE'S GYRUS GENERATOR, PK FORCEPS INSTRUMENTS AND PK INSTRUMENT CORD FOUND THAT ALL OF THE COMPONENTS USED FUNCTIONED WITHOUT ANY ISSUES NOTED. THE PK FORCEPS INSTRUMENTS FIRED WHEN CAUTERY ENERGY WAS ACTIVATED. REVIEW OF THE SITE'S SYSTEM LOGS BY THE FSE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE SITE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO OPEN AS A RESULT OF NOT BEING ABLE TO USE THE PK DISSECTING FORCEPS INSTRUMENT TO CONTROL THE PATIENT'S BLEEDING. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO ACTIVATE CAUTERY ENERGY USING THE PK DISSECTING FORCEPS INSTRUMENT WHILE ATTACHED TO THE GYRUS GENERATOR. THE SURGICAL STAFF RESEATED THE INSTRUMENT AND THE PK INSTRUMENT CORD; HOWEVER, THE ISSUE PERSISTED. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEER ASSISTANCE WHILE THE SURGEON WAS IN THE PROCESS OF CONVERTING THE CASE TO A TRADITIONAL OPEN SURGICAL PROCEDURE. THE SITE CONFIRMED WITH THE TSE THAT THE CAUTERY CABLE TO THE GYRUS GENERATOR WAS SEATED CORRECTLY. THE TSE SUGGESTED THAT THE SITE CHANGE THE PK INSTRUMENT CORD AND THE CAUTERY CABLE; HOWEVER, THE SITE DID NOT HAVE A SPARE PK INSTRUMENT CORD OR CAUTERY CABLE. THE TSE WAS UNABLE TO CONFIRM WITH THE SITE IF THE GYRUS GENERATOR WAS OPERATIONAL WHILE DISCONNECTED FROM THE DA VINCI SURGICAL SYSTEM. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT SHE WAS CIRCULATING DURING THE SURGICAL PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY GETTING THE PK DISSECTING FORCEPS INSTRUMENT TO FUNCTION. DURING THIS TIME THE PATIENT WAS BLEEDING AND THE SURGEON ATTEMPTED TO USE A BIPOLAR INSTRUMENT TO CONTROL THE BLEEDING HOWEVER, HIS ATTEMPTS WERE UNSUCCESSFUL. AS A RESULT, THE SURGEON MADE THE DECISION CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO QUICKLY CONTROL THE PATIENT'S BLEEDING AND TO COMPLETE THE SURGICAL PROCEDURE. IT WAS STATED THAT THE BLEEDING EXPERIENCED BY THE PATIENT WAS NOT DUE TO AN INJURY TO THE PATIENT; BUT RATHER NORMAL BLEEDING AS PART OF THE SURGICAL PROCEDURE. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND WAS GIVEN 4 BAGS OF RED BLOOD CELLS AND 2 UNITS OF PLASMA. THE PATIENT WAS STABILIZED. NO OTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. ON (B)(4) 2013, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT A FEW MINUTES INTO THE SURGICAL PROCEDURE, HE WAS UNABLE TO GET THE PK INSTRUMENT TO CAUTERIZE WHEN HE PRESSED THE FOOT PEDAL ON THE SURGEON SIDE CART. THE SURGEON INDICATED THAT HE OBSERVED THAT THE CAUTERY ICONS IN THE HIGH RESOLUTION STEREO (HRSV) SHOWED THAT CAUTERY ENERGY WAS ACTIVATED, BUT THE INSTRUMENT WAS NOT CAUTERIZING. THE BLEEDING EXPERIENCED BY THE PATIENT WAS DUE TO THE PATIENT'S FIBROIDS. UNABLE TO GET THE PK INSTRUMENT TO WORK, THE SURGEON ATTEMPTED TO USE A BIPOLAR INSTRUMENT, HOWEVER, HE WAS NOT GETTING THE DESIRED CAUTERY AND THEREFORE MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN. THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST OP. THE PATIENT WAS NOTED AS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396920 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other DA VINC SI SURGICAL INSTRUMENTS, ACCESSORIES & ES