BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 13256658 · Received January 13, 2022

    Report

    Report Number
    2955842-2022-10059
    Event Type
    Death
    Date Received
    January 13, 2022
    Date of Event
    August 14, 2021
    Report Date
    September 7, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SYSTEM ERROR LOG REVIEW WAS CONDUCTED FOR THE PROCEDURE PERFORMED ON (B)(6) 2021 USING SYSTEM (B)(4). THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED BY THE CUSTOMER TO ISI FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY WAS PERFORMED AND NO OTHER COMPLAINTS RELATED TO THIS EVENT WERE IDENTIFIED. A REVIEW OF THE EVENT INFORMATION PROVIDED WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING WAS NOTED: ACCORDING TO THE INFORMATION IN THE DESCRIPTION OF EVENTS, THE PATIENT, WITH A HISTORY OF END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS, DIED DUE TO AN INTRA-LUMINAL GASTRO-INTESTINAL BLEED APPROXIMATELY 7 TO 9 DAYS AFTER UNDERGOING A DA VINCI-ASSISTED PARA-ESOPHAGEAL HERNIA REPAIR. THE CAUSE OF THE INTRA-LUMINAL BLEEDING AND SUBSEQUENT ACUTE BLOOD LOSS ANEMIA THAT LED TO THE PATIENT¿S DEATH WAS DUE TO THE PATIENT¿S PAST MEDICAL HISTORY. THERE IS NO INFORMATION TO SUGGEST A USER OR USE ERROR. THE INTRA-LUMINAL (INSIDE THE STOMACH/INTESTINE) GASTROINTESTINAL BLEED RESULTED FROM THE PATIENT¿S UNDERLYING MEDICAL CONDITION. THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO VOMITING OF BLOOD TWO WEEKS AFTER A DA VINCI-ASSISTED PROCEDURE. THE PATIENT ULTIMATELY EXPIRED. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE COMPLAINT REVIEW.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED BY THE SITE'S ROBOTICS COORDINATOR AND A NURSE THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PARAESOPHAGEAL HERNIA REPAIR PROCEDURE, THE PATIENT RETURNED TO THE ER TWO DAYS AFTER BEING DISCHARGED AND EXPIRED DUE TO A ¿GI BLEED.¿ THE PATIENT HAD A HIATAL HERNIA WITH OBSTRUCTION AND STOMACH DISTENDED ON BOTH SIDES OF THE DIAPHRAGM. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI PROCEDURE. THE PATIENT HAD A NON-INCIDENTAL RECOVERY WITH NO COMPLICATION AND NO EARLY READMISSION. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON TO OBTAIN ADDITIONAL INFORMATION ON THIS EVENT: THE SURGEON TOOK DOWN THE SHORT GASTRICS DURING THE DA VINCI-ASSISTED PROCEDURE. NO LARGE VESSELS WERE TAKEN AND THERE WERE NO OBSERVED ENGORGED BLOOD VESSEL OR ANYTHING ABNORMAL. THERE WERE NO SIGNS OF ACTIVE BLEEDING AND NO DRAINS WERE PLACED. THE SURGEON REPORTED THE DA VINCI-ASSISTED PROCEDURE WENT WELL WITH NO INTRA-OPERATIVE ISSUES. A CHEST X-RAY WAS PERFORMED ON POST-OPERATIVE DAY ONE AND THERE WAS NO REOCCURRENCE OF THE HERNIA NOR ANY OTHER ISSUES IDENTIFIED. THE PATIENT WAS A LITTLE DEMENTED AND HAD SOME ISSUES WITH NOT EATING MUCH BUT TOLERATED HER UNSPECIFIED DIET WELL. THE PATIENT STAYED IN THE HOSPITAL FOR ONE WEEK DUE TO NUTRITION AND MONITORING LAB LEVELS AND RECEIVED DIALYSIS DURING RECOVERY. DURING THE WEEK, THE PATIENT DID NOT EXPERIENCE MUCH PAIN AND THERE WAS NO KNOWN SPECIFIC OR ACTIVE BLEEDING BUT THE PATIENT¿S HEMOGLOBIN LEVELS ¿KEPT DRIFTING DOWN¿ SO A UNIT OF BLOOD WAS TRANSFUSED. THE SURGEON DIDN'T UNDERSTAND WHY THE HEMOGLOBIN LEVELS WERE LOWERING, ¿ESPECIALLY SINCE THE PATIENT WAS ON DIALYSIS.¿ THE PATIENT WAS DISCHARGED ONE WEEK POST-OPERATION. TWO DAYS AFTER THE PATIENT WAS DISCHARGED, THE PATIENT WAS BROUGHT BACK TO THE ER BY AMBULANCE BECAUSE THE PATIENT WAS VOMITING BLOOD. LIFE SAVING MEASURES SUCH AS CHEST COMPRESSIONS WERE ATTEMPTED BUT THE PATIENT EXPIRED. THE SURGEON SAID THAT THE PATIENT ¿CODED RIGHT AWAY¿; THERE WAS ¿NO TIME TO DO MUCH BEFORE SHE DIED.¿ THE CAUSE OF DEATH ON THE DISCHARGE SUMMARY WAS LISTED AS GASTROINTESTINAL HEMORRHAGE; UNSPECIFIED. WHILE THE CAUSE AND SOURCE OF THE BLEEDING WERE NOT SPECIFIED, THE SURGEON SAID THAT THE REASON THE PATIENT DIED WAS A ¿STRESS ULCER FROM A GI BLEED.¿ SINCE THE PATIENT WAS VOMITING BLOOD, THE SOURCE OF THE BLEEDING WAS ISOLATED TO WITHIN THE GI TRACT. THE PATIENT¿S CAUSE OF DEATH WAS BELIEVED TO HAVE BEEN DUE TO ACUTE BLOOD LOSS DUE TO A STRESS ULCER FROM A GI BLEED AND THE PATIENT¿S POOR CONDITION. THE SURGEON SAID THAT, ¿THE ROBOT DIDN'T KILL HER¿ AND THAT THE PATIENT ¿JUST WAS NOT IN THE BEST OF SHAPE.¿ THE PATIENT ¿DIDN'T MAKE BLOOD CELLS LIKE USUAL.¿ THE SURGEON SAID THAT THE PATIENT HAD A PROPENSITY FOR BLEEDING DUE TO DIALYSIS AND PLATELET COUNTS. THE SURGEON BELIEVES THAT AN AUTOPSY MIGHT BE PERFORMED BUT IS NOT SURE AND, AT THIS POINT, THERE IS NO AUTOPSY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730134 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES