BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4853726 · Received June 18, 2015

    Report

    Report Number
    2955842-2015-00916
    Event Type
    Death
    Date Received
    June 18, 2015
    Date of Event
    May 27, 2014
    Report Date
    May 22, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL MEDICAL RECORDS IN RELATION TO THE REPORTED EVENT. ALTHOUGH THE DA VINCI OPERATIVE REPORT NOTES THAT THERE WERE NO COMPLICATIONS, THE SURGEON NOTED, THERE WAS A SMALL SEROSAL DEFECT AT THE RECTOSIGMOID COLON TO THE LEFT LOWER QUADRANT WHERE IT WAS DENSELY ATTACHED TO THE ABDOMINAL WALL AND THIS WAS OVERSEWN WITH TWO INTERRUPTED 3-0 VICRYL SUTURES. THE BOWEL DEFECT WAS FOUND AFTER THE ROBOT HAD BEEN DOCKED AND ADHESIONS FROM THE RECTOSIGMOID COLON TO THE LEFT LOWER QUADRANT WERE PROGRESSIVELY LYSED. PER A PATHOLOGY REPORT DATED (B)(6) 2014, THE LEFT COLON AND OMENTUM SHOWED A PERFORATED COLON WITH DIFFUSE PERITONITIS AND MULTIFOCAL EARLY ISCHEMIC COLITIS. ISI RECEIVED THE PATIENT'S DEATH SUMMARY. THE DISCHARGE DIAGNOSIS CONSISTED OF CARDIOPULMONARY ARREST SECONDARY TO PERFORATED DISKUS. ISI ALSO RECEIVED THE PATIENT'S NOTIFICATION OF DEATH FORM WHICH STATES THAT THE PATIENT'S CAUSE OF DEATH WAS SEPTIC SHOCK. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A PERFORATED COLON WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY FROM SEPTIC SHOCK. HOWEVER, THE ROOT CAUSE OF THE BOWEL DAMAGE IS UNKNOWN AT THIS TIME.

    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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE 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 EXTRA FASCIAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2014 FOR UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM. DURING THE SAME PROCEDURE, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY, WASHINGS, LYSIS OF ADHESIONS, AND PELVIC SENTINEL LYMPH NODE REMOVAL. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT IN ADDITION TO PATIENT MEDICAL AND LEGAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A LEGAL DOCUMENT PROVIDED CLAIMS THAT THE SURGEONS CUT, NICKED, TORE, BURNED OR OTHERWISE DISRUPTED THE SIGMOID COLON IN ONE OR MORE LOCATIONS. IN ADDITION, THE LEGAL DOCUMENT NOTES, IN AN ATTEMPT TO REPAIR ONE OF THE INJURIES TO THE SIGMOID COLON, THE SURGEONS PLACED SUTURES. PER THE DA VINCI OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED THE FOLLOWING: THE LAPAROSCOPY REVEALED SOME PERIHEPATIC ADHESIONS. SHE HAD SOME ADHESIONS IN THE PELVIC AREA IN THE SITE OF HER PREVIOUS SURGERY. BIOPSY FROM THIS AREA SHOWED GRANULATION TISSUE WITH NO OBVIOUS MALIGNANCY. THE RECTOSIGMOID COLON WAS DENSELY ADHERENT TO ONE OF THE PREVIOUS PRESUMABLY TROCAR SITES AND THE PATIENT WAS STATUS POST-LEFT SALPINGO-OOPHORECTOMY. NO COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 30 CCS. ON (B)(6) 2015 THE PATIENT'S HUSBAND ATTEMPTED TO CONTACT THE SURGEON SINCE THE PATIENT HAD COMPLAINTS OF DIFFICULTY BREATHING. THE ON-CALL PHYSICIAN RECOMMENDED FOR THE PATIENT TO TAKE ORAL PAIN MEDICATIONS AND TO CALL BACK IF NEEDED. ON (B)(6) 2015, THE PATIENT AND HER HUSBAND ATTEMPTED TO CONTACT THE SURGEON AGAIN DUE TO COMPLAINTS OF BILATERAL THIGH PAIN, AND TONGUE NUMBNESS. DURING THE CALL, THE PATIENT WAS NOTED TO HAVE SLURRED SPEECH. THE PATIENT AND HER HUSBAND WERE INSTRUCTED TO VISIT THE NEAREST HOSPITAL FOR EVALUATION TO RULE OUT BLOOD CLOTS OR A STROKE. ON (B)(6) 2014, THE PATIENT PRESENTED TO AN EMERGENCY ROOM (ER) WITH COMPLAINTS OF NAUSEA, VOMITING, DIARRHEA, ABDOMINAL PAIN, AND SHORTNESS OF BREATH. THE PATIENT REPORTEDLY COLLAPSED IN THE ER. THE PATIENT WAS INTUBATED. HER INITIAL BLOOD PRESSURE WAS 53/23. THE ER IMPRESSION REVEALED SEPSIS SYNDROME WITH SHOCK, MULTISYSTEM ORGAN DYSFUNCTION, AND RESPIRATORY FAILURE. THAT SAME DAY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, AND A LEFT HEMICOLECTOMY WITH END TRANSVERSE COLOSTOMY AND HARTMAN POUCH PROCEDURE. OPERATIVE FINDINGS INCLUDED A PERFORATION OF THE SIGMOID COLON AT AN AREA WHERE THERE WAS EVIDENCE OF PRIOR SURGICAL DISSECTION. SEVERE FECULENT AND PURULENT PERITONITIS WAS FOUND DIFFUSELY IN THE ABDOMINAL CAVITY. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE ICU IN CRITICAL CONDITION ON MAXIMAL PRESSURES AND SUPPORTIVE CARE. ACCORDING TO THE LEGAL DOCUMENTS, THE PATIENT REPORTEDLY PASSED AWAY ON (B)(6) 2014 FROM COMPLICATIONS OF THE PERFORATED SIGMOID COLON, FECULENT PURULENT PERITONITIS, SEPTIC SHOCK AND MULTI-ORGAN FAILURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396610 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| H| R