BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3007725 · Received March 15, 2013

    Report

    Report Number
    2955842-2013-00857
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED SUPPLEMENTAL INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED COLON RESECTION FOR A COLO-VAGINAL FISTULA THOUGHT TO BE DUE TO ISCHEMIA. PREVIOUS INFORMATION OBTAINED OUTLINED THE NATURE OF THE INJURY AND THE IMMEDIATE POST-OPERATIVE CARE AT THE FORBES REGIONAL HOSPITAL. ADDITIONAL SUPPLEMENTAL RECORDS HAVE BEEN OBTAINED FROM THE PATIENT'S REHABILITATION HOSPITAL. THE PATIENT WAS HOSPITALIZED 3 TIMES AT THE REHAB AND NURSING CENTER AT (B)(6) ON THE FOLLOWING DATES: (B)(6) 2013. THESE HOSPITALIZATIONS WERE FOR HER MEDICAL CONDITIONS GENERALLY RELATED TO THE PATIENT'S UNDERLYING CONDITION AND SURGICAL AFTERCARE FROM MAJOR SURGERY FOR COLON CANCER. THERE WERE NO DIRECT SEQUELAE OF THE ALLEGED ROBOTIC SURGERY INJURY TO THE AORTA BUT RATHER COMPLICATIONS OF THE UNDERLYING CANCER CONDITION.

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI COLON RESECTION FOR COLOVAGINAL FISTULA ON (B)(6) 2013. THE LEGAL COMPLAINT ALLEGES THAT DURING SURGERY THE ROBOTIC ARM MALFUNCTIONED AND THE ATTACHED INSTRUMENT INJURED THE PATIENT'S AORTA. A SUCCESSFUL REPAIR WAS UNDERTAKEN VIA LAPAROTOMY. ON (B)(6) 2014, ISI WAS PROVIDED WITH SUPPLEMENTAL MEDICAL RECORDS OF THE DA VINCI SURGERY. THE OPERATIVE REPORT CONTENDS THAT A SPONTANEOUS MOVEMENT OF THE ROBOTIC ARM 1 RESULTED IN THE HARMONIC SCALPEL INSTRUMENT JUMPING FORWARD AND PIERCING THE PATIENT'S AORTA. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT AT ONE POINT DURING SURGERY, THE HARMONIC SCALPEL STOPPED RESPONDING TO MY COMMANDS AT THE CONSOLE. THE SURGEON THEN NOTED THAT A QUICK CHECK AT THE BEDSIDE WAS UNDERTAKEN AND NO UNUSUAL ABNORMALITY WAS NOTED AND THEN SUDDENLY THE HARMONIC THRUST FORWARD UNPROMPTED AND WITHOUT COMMAND PIERCING THE RETROPERITONEUM. IT IS UNKNOWN IF THE SURGEON RELEASED THE MASTER TOOL MANIPULATORS (MTM) WHILE HIS HEAD WAS WITHIN THE HIGH RESOLUTION STEREO VIEWER (HRSV) WHEN THE EVENT OCCURRED. THE MASTER TOOL MANIPULATOR (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). THE SURGEON WAS UNABLE TO STOP IMMEDIATE BLEEDING THAT HAD ENSUED AND THE DECISION WAS THEN MADE TO CONVERT TO OPEN SURGICAL TECHNIQUES. AFTER A LAPAROTOMY INCISION WAS MADE, THE SURGEON WAS ABLE TO STOP THE BLEEDING WITH PRESSURE. AT THAT POINT, THE ESTIMATED BLOOD LOSS WAS 500 TO 750 ML. A VASCULAR SURGEON WAS CALLED IN, REPAIR OF THE AORTA WITH SUTURES WAS PERFORMED, AND HEMOSTASIS WAS OBTAINED. THE APPROXIMATE BLOOD LOSS AT THAT POINT WAS 2 L. THE SURGEON WAS THEN ABLE TO COMPLETE THE SURGICAL PROCEDURE VIA OPEN SURGERY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION TO A REHAB NURSING FACILITY ON POST-OPERATIVE DAY 13.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE TO INSPECT THE PATIENT SIDE MANIPULATOR (PSM).HE PERFORMED A TEST DRIVE AND SINE CYCLE ON THE PSM WITH NO ISSUES. THE FSE ALSO INSPECTED THE INSTRUMENTS AND THE CANNULAE THAT WERE USED DURING THE PROCEDURE. THE FSE INSPECTED THE CANNULAE TO ENSURE THAT ALL WERE WITHIN SPECIFICATION. THE FSE FOUND ONE OUT OF SPECIFICATION. SITE CONFIRMED THAT THIS CANNULA WOULD BE TAKEN OUT OF ROTATION. ACCORDING TO THE SURGICAL STAFF, ALL CANNULAE ARE INSPECTED BEFORE THEY ARE RETURNED BACK INTO CIRCULATION. THE FSE ALSO INSPECTED THE INSTRUMENTS USED DURING THE PROCEDURE. THE HARMONIC ACE INSTRUMENT EXHIBITED LONG SCRATCHES AND GOUGE MARKS ON IT CONSISTENT WITH USE OF THE OUT OF SPECIFICATION CANNULA. SURGICAL STAFF CONFIRMED THAT THIS INSTRUMENT WOULD BE ALSO TAKEN OUT OF ROTATION. THE FSE INSPECTED THE PSM CABLE TENSION, AND ADJUSTED TO SPECIFICATION. THE FSE WAS UNABLE TO REPRODUCE THE EXACT CUSTOMER REPORTED FAILURE. ACCORDING TO THE INFORMATION PROVIDED TO THE FSE BY THE SURGICAL STAFF, THE PATIENT CONDITION WAS STABLE. NO REPORT OF ANY FURTHER COMPLICATIONS WAS MADE. A REVIEW OF THE SYSTEM LOGS SHOWED NO SYSTEM MALFUNCTION OCCURRING DURING THE PROCEDURE ON (B)(6) 2013. AS OF(B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCE OF THIS ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI SI SIGMOID COLECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED A PROBLEM WITH ONE OF THE PATIENT SIDE MANIPULATOR (PSM) ARMS. THE CUSTOMER REPORTED THAT THE PSM ARM 1 WAS NOT FOLLOWING THE MOVEMENTS OF THE SURGEON PROPERLY DURING THE CASE. IT WAS ALLEGED THAT THE BED SIDE ASSISTANT WAS LOOKING AT THE DRAPES WHEN THE ARM MOVED FORWARD AND CONTACTED THE PATIENT'S AORTA. THE CUSTOMER CONVERTED TO AN OPEN PROCEDURE AND A VASCULAR SURGEON WAS CALLED TO REPAIR THE DAMAGE. IT WAS ALSO REPORTED THAT THE SITE WAS UNSURE IF THE ARM WAS TOUCHED OR IF THE SURGEON HAD HIS HEAD IN THE VIEWER WITH HIS HANDS OFF THE MASTER. THE SURGEON REPORTED TO THE CLINICAL SALES REPRESENTATIVE: IT IS CLEAR TO ME THAT THERE WAS PENT UP ENERGY STORED ON THE ARM OF THE ROBOT. WHEN THIS WAS RELEASED THE INSTRUMENT SHOT FORWARD WITH A FORCE AND AT A SPEED GREATER THAN HUMANLY POSSIBLE. IT THEN APPEARED TO SET BACK HALF WAY BETWEEN THE STARTING POINT (WHERE IT WAS NOT FUNCTIONING) AND THE POINT OF MAXIMAL CONTACT IN THE RETROPERITONEUM. I AM NOT SURE WHETHER THE RECOIL AFTER THE STABBING WAS THE ROBOT RETURNING TO A REST OR ME INSTINCTIVELY PULLING BACK ON THE CONTROLS. THE INSTRUMENT INVOLVED IN THE INCIDENT WAS THE HARMONIC ACE INSTRUMENT IN PORT 1 IN THE RLQ (THE PORT ITSELF WAS PUSHED IN BEYOND THE REMOTE CENTER BECAUSE OF THE PATIENT'S BODY HABITUS AND THE NEED FOR ADDITIONAL LENGTH WHILE ADDRESSING THE FLEXURE). IT HAD BEEN WORKING NORMALLY UNTIL ABOUT 30 SECONDS PRIOR TO THE INCIDENT WHEN IT STOPPED RESPONDING TO COMMANDS AT WHICH POINT ISI TECHNICAL SUPPORT HAD THE OR STAF CHECK THE FIELD AND SHE IDENTIFIED NO PHYSICAL BARRIERS AND NOTED THERE WERE NO ERROR MESSAGES. THE OTHER ACTIVE INSTRUMENT WAS IN PORT 3 IN THE SUBXYPHOID AREA AND WAS FUNCTIONING NORMALLY THROUGHOUT. THE THIRD PORT (2) IN THE RLQ WAS INACTIVE WITH A PROGRASP FORCEPS INSTRUMENT GENTLY RETRACTING SMALL BOWEL IN THE PELVIS. THE 2 ACTIVE INSTRUMENTS WERE CLEARLY WITHIN VIEW THE WHOLE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109050 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES