BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4238472 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05635
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    February 27, 2013
    Report Date
    October 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. DURING THE SURGICAL PROCEDURE, A RECOVERABLE SYSTEM ERROR CODE 23003 POINTING TO PATIENT SIDE MANIPULATOR (PSM) 3 OCCURRED ONE TIME. IN THIS CASE, THE SYSTEM ERROR CODE 23003 SIGNIFIED THAT ON PSM 3 THE GRIP ANGLE DID NOT FOLLOW THE DESIRED ANGLE WITHIN THE SPECIFIED LIMIT. ALSO, MULTIPLE SYSTEM ERROR CODE 32003 OCCURRED DURING THE SURGICAL PROCEDURE. A SYSTEM ERROR CODE 32003 SIGNIFIES THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS COULD BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR ATTEMPTING TO CUT VERY THICK AND/OR UNSEALED TISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE AND EXPERIENCED INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS AND THEN SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE FOR A LEFT UPPER LOBE MASS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, ADHESIONS BETWEEN THE UPPER CHEST WALL AND THE LATERAL CHEST WALL OF THE LUNG WERE TAKEN DOWN USING HOOK CAUTERY. DISSECTION IN THE FISSURE PROCEEDED UNTIL SOME OF THE PULMONARY ARTERY BRANCHES COULD BE IDENTIFIED AND SEALED USING THE VESSEL SEALER INSTRUMENT. THE SURGEON NOTED, WE THEN WENT AHEAD AND CONTINUED WITH DISSECTION IN THE FISSURE UTILIZING AN ELECTROCAUTERY TO HELP EXPOSE WITH PULMONARY ARTERY...AT THIS POINT BECAUSE OF THE SIGNIFICANT ADHESIONS IN THE FISSURE, I WENT AHEAD AND DISSECTED PROXIMALLY IDENTIFYING THE PULMONARY VEIN. DISSECTION CONTINUED AND THE LUNG RESECTION WAS SUBSEQUENTLY COMPLETED. THE SURGEON INDICATED...AND AT THIS TIME I NOTED SOME BLEEDING COMING FROM THE TRUNCAL BRANCHES OF THE PULMONARY ARTERY. WE GRASPED WITH THE PROGRASP AND I APPLIED ANOTHER APPLICATION OF VESSEL SEALER JUST PROXIMALLY TO THIS. WHEN WE RELEASED THE PROGRASP, THE BLEEDING WAS INCREASED SO I WENT AHEAD AND GRABBED IT AGAIN AND WE PREPARED EMERGENTLY TO OPEN THE PATIENT. UPON OPENING THE CHEST THE SURGEON NOTED...WE CAN SEE THAT BASICALLY THE ANTERIOR TRUNCAL BRANCH OF THE PA NOW HAD BECOME WIDELY OPEN GREATER THAN PREVIOUSLY SEALED WITH TWO APPLICATIONS OF THE VESSEL SEALER. THE VESSEL DEFECT WAS SUBSEQUENTLY REPAIRED WITH A PLEDGETED SUTURE OF 3-0 PROLENE. A MEDIASTINAL LYMPHADENECTOMY WAS ALSO PERFORMED. THE TOTAL ESTIMATED BLOOD LOSS WAS 2,500 ML AND THE PATIENT RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS IN THE OR. THE PATIENT WAS TRANSFERRED TO THE CICU. THE PATIENT WAS NOTED TO HAVE EXCELLENT NEUROLOGIC RECOVERY, AND WAS EXTUBATED ON POST-OP DAY 2. THE PATIENT WAS SUBSEQUENTLY NOTED, HOWEVER, TO HAVE A SIGNIFICANT AIR LEAK FROM HER SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND ABRASIONS TO LUNG TISSUE AT THE TIME OF SURGERY. ON (B)(6) 2013, THE PATIENT DEVELOPED A SUDDEN ONSET OF ASYSTOLE CARDIAC ARREST IN THE ICU AND WAS SUCCESSFULLY RESUSCITATED. SHE DEVELOPED SEIZURES THAT MORNING AND IT WAS DETERMINED THAT SHE SUFFERED IRREVERSIBLE NEUROLOGIC DAMAGE. THE FAMILY REQUESTED THAT SUPPORT BE WITHDRAWN, AND THE PATIENT EXPIRED ON (B)(6) 2013. AN AUTOPSY WAS NOT PERFORMED. PER THE DEATH CERTIFICATE, THE PATIENT'S CAUSE OF DEATH WAS IDENTIFIED AS HYPOXIC ENCEPHALOPATHY DUE TO OR AS A CONSEQUENCE OF CARDIAC ASYSTOLE. SHE WAS NOTED TO BE POST-OPERATIVE FOR A LUNG MASS WITH A DIAGNOSIS OF NSC (NON-SMALL CELL) LUNG CANCER. AN UNDERLYING CAUSE OF DEATH WAS NOTED AS COPD ON VENTILATOR POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720293 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| L| R