BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3092868 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01539
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, ISI CONTACTED (B)(6) WHO INITIALLY REPORTED THIS EVENT. THE CSM INDICATED THAT THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE REPORTED TO HIM THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, PERFORMED ON (B)(6) 2013, THE BEDSIDE ASSISTANT INADVERTENTLY PUSHED AN UNKNOWN ENDOWRIST INSTRUMENT INSTALLED ON A PATIENT SIDE MANIPULATOR (PSM) ARM INTO THE PATIENT'S LEFT COMMON ILIAC VEIN. THE DAMAGE TO THE PATIENT'S VESSEL CAUSED UNCONTROLLED BLEEDING AND APPROXIMATELY 4 MINUTES AFTER THE INTRA-OPERATIVE INJURY OCCURRED THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES TO ACHIEVE HEMOSTASIS. PER THE CSM, THE SURGEON INDICATED TO HIM THAT NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THE SPECIFIC INSTRUMENT INSTALLED ON THE PSM AT THE TIME OF THE PATIENT'S INJURY WAS NOT PROVIDED TO THE CSM. THE CSM INDICATED THAT HE WAS TOLD BY THE SURGEON THAT THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS; HOWEVER, HEMOSTASIS WAS ACHIEVED AFTER HE (SURGEON) CONVERTED THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE PATIENT EXPIRED ON (B)(6) 2013 AS A RESULT OF SIGNIFICANT BLOOD LOSS AND MULTIPLE ORGAN FAILURE. PER THE CSR THE SURGICAL PROCEDURE WAS RECORDED BY THE SITE; HOWEVER, THE VIDEO WAS NOT AVAILABLE FOR REVIEW. THE CSR ALSO INDICATED THAT THE SURGEON TOLD HIM THAT A PRIVATE PATHOLOGIST CONDUCTED AN AUTOPSY; HOWEVER, THE AUTOPSY REPORT WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2013, THE ISI CSM ASSIGNED TO THE SITE ALSO SPOKE DIRECTLY TO THE SURGEON. THE SURGEON INFORMED THE CSM THAT THE PATIENT UNDERWENT A DA VINCI SI RADICAL HYSTERECTOMY AND THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE CSM INDICATED THE SURGEON TOLD HIM THAT THE PATIENT WAS STABLE UPON CLOSURE AT THE END OF THE OPERATION AND THAT THE SURGEON DENIED THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON AN UNSPECIFIED DATE; HOWEVER, A FEW DAYS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE PATIENT RETURNED TO THE HOSPITAL AND IT WAS DETERMINED THAT THE PATIENT REQUIRED AN OPEN SURGICAL PROCEDURE. DURING THE OPEN SURGICAL PROCEDURE, THE SURGEON DISCOVERED THAT THE PATIENT HAD EXPERIENCED INTERNAL BLEEDING INTERNALLY FOR AN UNKNOWN PERIOD OF TIME. THE CSM INDICATED THAT THE SURGEON REVIEWED THE DA VINCI PROCEDURE VIDEO. THE SURGEON INDICATED THAT BASED ON HIS REVIEW OF THE VIDEO, THE VIDEO DID NOT SHOW THAT THE PATIENT EXPERIENCED ANY SIGNIFICANT INTERNAL BLEEDING DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE. THE SURGEON INDICATED TO THE CSM THAT REVIEW OF THE VIDEO DID NOT SHOW THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED. THE CSM WAS TOLD BY THE SURGEON THAT HE BELIEVES THAT THE INTERNAL BLEEDING EXPERIENCED BY THE PATIENT WAS THE RESULT OF DAMAGE TO THE PATIENT'S LEFT COMMON ILIAC VEIN, THAT OCCURRED AFTER THE BEDSIDE ASSISTANT INADVERTENTLY PUSHED A LAPAROSCOPIC SUCTION IRRIGATOR INSTRUMENT INSTALLED IN AN ASSIST PORT INTO THE PATIENT'S VESSEL. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER INDICATED THAT SHE WAS UNABLE TO DISCLOSE ANY INFORMATION REGARDING THE CAUSE OF THE PATIENT'S DEMISE AND WOULD NOT BE ABLE TO PROVIDE THE PATIENT'S MEDICAL RECORDS. THE RISK MANAGER INDICATED THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. ISI REVIEWED THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, SHOWED THAT THERE WAS NO MALFUNCTION OF THE SITE'S DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, THE SITE'S SYSTEM LOGS SHOWED THAT THERE WAS NO USE OF AN ISI SUCTION IRRIGATOR INSTRUMENT DURING THE SURGICAL PROCEDURE. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES MALFUNCTIONED IN A WAY THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT AND OBTAINED CLARIFICATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT NEAR THE END OF THE CASE AND DURING APPLICATION OF A HEMOSTATIC AGENT FOR SEALING, HE HAD THE NEEDLE DRIVER INSTRUMENT IN HIS RIGHT HAND AND THE GRASPER INSTRUMENT IN HIS LEFT HAND. THE SURGEON'S RIGHT HAND WAS OUT OF VIEW AND THE PATIENT SIDE ASSISTANT'S 3RD-PARTY LAPAROSCOPIC SUCTION IRRIGATOR INSTRUMENT WAS OUT OF VIEW BRIEFLY WHILE THE CAMERA WAS MOVED CEPHALAD TO VIEW A DIFFERENT AREA OF THE PATIENT'S ANATOMY. AT THAT TIME, THE SURGEON NOTICED POOLING BLOOD. WHEN THE SURGEON MOVED THE CAMERA BACK TO LOOK AT THE PELVIC AREA, SIGNIFICANT BLEEDING WAS SEEN. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING FOR 4-5 MINUTES BUT WAS UNSUCCESSFUL. A VASCULAR SURGEON WAS CALLED IN AND THE CASE WAS CONVERTED TO OPEN TRADITIONAL SURGICAL TECHNIQUES. THE VASCULAR SURGEON REPAIRED THE ILIAC VEIN AND CLOSED THE PATIENT. APPROXIMATELY 1 HOUR LATER, THE PATIENT WAS NOT STABLE AND A SECONDARY OPERATION WAS PERFORMED FOR FURTHER REPAIRS AT THE SAME SITE OF THE PREVIOUS BLEEDING. THE DETAILS OF THE SECONDARY OPERATION WERE NOT PROVIDED. THE PATIENT PASSED AWAY 2 DAYS LATER DUE TO MULTIPLE COMPLICATIONS LIKELY DUE TO BLOOD LOSS. ISI HAS REVIEWED THE SYSTEM LOGS FOR THIS PROCEDURE AND CONFIRMED THAT NO DA VINCI SYSTEM ERRORS WERE ASSOCIATED WITH THE INJURY TO THE ILIAC VEIN. AT THIS TIME, THERE IS NO EVIDENCE THAT THE DA VINCI SI SYSTEM, OR A DA VINCI INSTRUMENT OR ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY TO THE VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES FOR AN UNKNOWN REASON AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194228 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P7

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES