BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

    MDR report key: 4238460 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05633
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    January 23, 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 HIS 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. 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 CAUSE OF THE PATIENT'S POST-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 TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, PERIAORTIC LYMPHADENECTOMY, SELECTIVE BILATERAL PELVIC LYMPH NODE BIOPSIES, AND OBSERVATION CYSTOSCOPY FOR HIGH GRADE ENDOMETRIOID TYPE UTERINE CARCINOMA 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, THE SURGEON NOTED THAT DISCRETE NODES WERE NOT IDENTIFIED SO PERIAORTIC DISSECTION WAS INCORPORATED WITH COMPLETE DISSECTION OF THE AREA. A COLPOTOMY INCISION WAS PERFORMED. THE SURGEON NOTED, AT ONE POINT THE COLPOTOMY INCISION WAS HIGH AND THERE WAS ENTRY, PROBABLY INTO THE LOWER ISTHMUS. THE SURGEON INDICATED THAT THIS WAS CORRECTED WITH A LOWER COLPOTOMY INCISION. THE PATIENT'S VAGINA WAS CLOSED WITH A 0 RUNNING V-LOC SUTURE AND THE UTERUS WAS DELIVERED WITHOUT DIFFICULTY. THE SURGEON THEN PERFORMED SELECTIVE PELVIC LYMPH NODE BIOPSIES ON THE RIGHT AND LEFT, STARTING FROM THE DISTAL COMMON ILIAC TO THE CIRCUMFLEX, ALONG THE EXTERNAL ILIAC ARTERY AND VEIN AND PROXIMAL HYPOGASTRIC ARTERY. THE SURGEON NOTED THAT BLOOD LOSS WAS MINIMAL AND THE PATIENT WAS RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT DEVELOPED POST-OP CARDIAC ARRHYTHMIA AND WENT INTO CARDIAC ARREST REQUIRING RESUSCITATION. THE PATIENT GRADUALLY IMPROVED. HOWEVER, THE PATIENT DEVELOPED SYMPTOMS OF A BOWEL OBSTRUCTION WHICH WAS CONFIRMED PER A CT-SCAN AS A POSSIBLE PORT SITE INCARCERATED HERNIA WITH INTRATHORACIC STOMACH. ON (B)(6) 2013 AN EXPLORATORY LAPAROTOMY WAS PERFORMED. IN ADDITION, RELEASE OF THE BOWEL OBSTRUCTION, REPAIR OF THE INCARCERATED LEFT ABDOMINAL WALL HERNIA, REPAIR OF A RIGHT LOWER QUADRANT HERNIA, SMALL BOWEL RESECTION, REPAIR OF A SEROSAL TEAR OF THE BOWEL X2, REDUCTION OF STOMACH FROM CHEST AND GASTROPEXY WERE PERFORMED. FINDINGS INCLUDED AN INCARCERATED PORT HERNIA JUST LEFT OF MIDLINE. THERE WAS AN OPENING OF THE TROCAR [SITE] WHICH WAS NOT CLOSED OR SEALED IN THE RIGHT LOWER QUADRANT. THERE WERE SOME TEARS IN THE BOWEL SEROSA WITH BOWEL DISTENTION. THERE WAS ISCHEMIC SMALL BOWEL APPROXIMATELY 1 FOOT FROM THE LIGAMENT OF TREITZ AND THE STOMACH WAS BASICALLY IN THE PATIENT'S CHEST. THE PROCEDURE WAS NOTED TO BE SUCCESSFUL AND THE PATIENT WAS SENT TO ICU. THE PATIENT WAS PRONOUNCED DECEASED ON (B)(6) 2013 AT 3:14 PM. ACCORDING TO THE PATIENT'S DEATH CERTIFICATE, THE CAUSE OF DEATH WAS IDENTIFIED AS CARDIOPULMONARY FAILURE, SMALL BOWEL OBSTRUCTION, AND UTERINE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720289 ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| L| R