BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3872847 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03641
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    December 9, 2008
    Report Date
    May 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE. ISI HAS CONTACTED 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT'S RENAL ARTERY WAS PERFORATED DURING A DA VINCI SURGICAL PROCEDURE PERFORMED ON (B)(6) 2008 AND THE PATIENT SUBSEQUENTLY PASSED AWAY 5 YEARS LATER ON (B)(6) 2013 FROM METASTATIC RENAL CANCER. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE INJURY IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT'S SUBSEQUENT DEMISE IS RELATED TO THE DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS RELATED TO THE REPORTED EVENT. THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION, SIGNIFICANT LYSIS OF ADHESIONS, INITIAL DISSECTION, AND THEN CONVERSION TO OPEN RADICAL NEPHRECTOMY WITH NEAR COMPLETE URETERECTOMY AND RETROPERITONEAL LYMPH NODE DISSECTION ON (B)(6) 2008 FOR A RIGHT RENAL MASS. PER THE OPERATIVE REPORT, THE PATIENT HAD SIGNIFICANT ADHESIONS THAT REQUIRED IN EXCESS OF 1.5 HOURS OF DISSECTION TO GAIN LAPAROSCOPIC ACCESS AND A WORKING SPACE. HE WAS ALSO NOTED TO HAVE 2 RENAL VEINS: 1 ANTERIOR TO THE ARTERY AND 1 INFERIOR AND MEDIAL TO THE ARTERY. ONCE THIS WAS IDENTIFIED, THE ANTERIOR VESSEL WAS COMPLETELY DISSECTED FREE. THE POSTERIOR VESSEL WAS BEING DISSECTED PRIOR TO ACCESSING THE ARTERY AND, AT THIS TIME, A SMALL OPENING WAS MADE IN THE VEIN WHICH UNFORTUNATELY COULD NOT BE CONTROLLED WITH THE 2 FUNCTIONING PORTS OF THE ROBOT. IT WAS AT THIS TIME THAT IT WAS DECIDED TO OPEN. THE SURGERY CONTINUED TO COMPLETION, WITH AN ESTIMATED BLOOD LOSS OF 1900 ML. FIVE UNITS OF PACKED RED BLOOD CELLS AND FFP [FRESH FROZEN PLASMA] WERE ADMINISTERED INTRA-OPERATIVELY. POST-OPERATIVELY, THE PATIENT WAS STARTED ON HEMODIALYSIS FOR SUSPECTED TUBULAR NECROSIS FROM INTRAOPERATIVE LEFT RENAL ISCHEMIA. HE CONTINUED TO RECEIVE INTERMITTENT HEMODIALYSIS DURING THE HOSPITALIZATION, WITH THE LAST REQUIRED DIALYSIS ON (B)(6) 2008. THE PATIENT ALSO DEVELOPED A SMALL WOUND INFECTION. BY POST-OPERATIVE DAY 18, THE PATIENT'S CREATININE HAD TRENDED DOWN, ALTHOUGH IT WAS STILL ELEVATED, AND HE WAS MAKING GOOD URINE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2008 TO (B)(6) 2008. PER THE MEDICAL RECORDS PROVIDED, THE PATIENT RETURNED TO THE OR ON (B)(6) 2009 AND UNDERWENT FLANK WOUND EXPLORATION WITH EXCISION OF NECROTIC TISSUE AND DRAINAGE FOR A NON-HEALING FLANK WOUND. THE DATES OF HOSPITALIZATION ARE UNKNOWN. PER THE PATIENT'S DEATH CERTIFICATE, THE PATIENT EXPIRED ON (B)(6) 2010 DUE TO RENAL CELL CARCINOMA. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THIS COMPLAINT IS STILL BEING REPORTED BECAUSE IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE VESSEL INJURY AND IF THE DA VINCI SURGICAL PROCEDURE LED TO THE PATIENT'S SUBSEQUENT DEMISE 5 YEARS LATER.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO REPORTEDLY UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - NEPHRECTOMY FOR RENAL MASS ON (B)(6) 2008. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. ISI WAS ONLY PROVIDED A LEGAL CLAIM FORM. THE LEGAL DOCUMENT STATES THAT ON (B)(6) 2008, THE PATIENT UNDERWENT ROBOTIC SURGERY FOR REMOVAL OF A RENAL MASS. DURING THE ROBOTIC SURGERY THE ROBOT PERFORATED THE PATIENT'S ARTERY LEADING TO IS [SIC] OTHER KIDNEY. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT AS A RESULT, THE PATIENT WAS NOT A CANDIDATE TO RECEIVE THE CANCER TREATMENT, INTERLEUKIN II, TO FIGHT HIS KIDNEY CANCER. THE PATIENT PASSED AWAY ON (B)(6) 2013 FROM METASTATIC RENAL CANCER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349953 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| R