BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3634742 · Received February 19, 2014

    Report

    Report Number
    2955842-2014-00973
    Event Type
    Death
    Date Received
    February 19, 2014
    Date of Event
    November 30, 2009
    Report Date
    January 20, 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 OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT; HOWEVER, THE PROVIDED AUTOPSY REPORT INDICATED THAT THE PATIENT'S UNDERLYING VASCULAR DISEASE LED TO THE PATIENT'S POST OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY EXPIRED AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND AN EXPLORATORY LAPAROTOMY PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE FOR RENAL CELL CARCINOMA OF THE LEFT KIDNEY ON (B)(6) 2009 AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2009. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AS WELL AS PATHOLOGY REPORT, AUTOPSY REPORT, VARIOUS HOSPITAL RECORDS, AND DEATH CERTIFICATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING THE DA VINCI SURGERY IN THE PROVIDED RECORDS. THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2009 INDICATED THAT THE PATIENT WAS A (B)(6) MALE WITH A 3-4 CM SOLID ENHANCING TUMOR IN THE MIDDLE OF THE KIDNEY, CONSISTENT WITH RENAL CELL CARCINOMA. THE PATIENT OPTED TO UNDERGO A NEPHRECTOMY OF THE LEFT KIDNEY AND THE SURGEON HAD DISCUSSED THE RISKS OF THE SURGERY. NO INJURIES WERE NOTED TO ADJACENT ORGANS, INCLUDING SPLEEN, BOWEL, OR GREAT VESSELS. THERE WAS LESS THAN 300 ML OF BLOOD LOSS AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION OR MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. AN OPERATIVE REPORT DATED (B)(6) 2009 INDICATED THAT THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, WHICH REVEALED ISCHEMIA OF THE LEFT COLON WITHOUT EVIDENCE OF PERFORATION. A LEFT COLECTOMY AND AN END TRANSVERSE COLOSTOMY WERE PERFORMED. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ANOTHER MEDICAL RECORD DATED (B)(6) 2009 INDICATED THAT THE PATIENT HAS A BLOOD PRESSURE OF 86/27, WAS IN SEVERE SEPTIC SHOCK AND WAS NOT RESPONSIVE TO MEDICATIONS, INCLUDING ANTIBIOTICS. THE PATIENT ALSO HAD ACUTE RENAL FAILURE, WHICH WAS POSSIBLY SECONDARY TO SEPTIC SHOCK. THE ANATOMICAL PATHOLOGY RESULTS REPORT DATED (B)(6) 2009 INDICATED THAT THE PATIENT DEVELOPED ABDOMINAL PAIN APPROXIMATELY 1-2 DAYS POSTOP AND EXPLORATORY SURGERY WAS PERFORMED. THE SURGERY REVEALED AREAS OF ISCHEMIA OF HIS LEFT COLON. A LEFT COLECTOMY WAS PERFORMED WITH CREATION OF COLOSTOMY. FOLLOWING THIS SURGERY, HE PROGRESSIVELY DETERIORATED AND EXPIRED ON (B)(6) 2009. ALL SURGICAL SITES WERE INSPECTED AND WERE INTACT WITHOUT EVIDENCE OF HEMORRHAGE OR BREAKDOWN. THE PATIENT HAD SIGNIFICANT ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE AND SHOWED EVIDENCE OF DENSE PLAQUES WITHIN HIS AORTA. THE REPORT'S CASE SUMMARY INDICATED, IN ALL LIKELIHOOD, HIS UNDERLYING VASCULAR DISEASE LEAD TO A SUDDEN ISCHEMIC OCCURRING POSTOPERATIVELY. THIS RESULTED IN THE PROGRESSIVE BOWEL ISCHEMIA WITH SUBSEQUENT NECROSIS, CENTRILOBULAR AND NECROTIC CHANGES WITHIN LIVER, AND PLEURAL EFFUSIONS. IT ALSO INDICATED THAT BASED ON THE AUTOPSY EVALUATION, THE MANNER OF THE PATIENT'S DEATH WAS NATURAL AND THE CAUSE OF DEATH WAS NOTED AS EXTENSIVE BOWEL ISCHEMIA WITH NECROSIS, STATUS POST LEFT NEPHRECTOMY AND LEFT COLECTOMY WITH COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105284 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| R