BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 18146612 · Received November 16, 2023

    Report

    Report Number
    2955842-2023-20382
    Event Type
    Death
    Date Received
    November 16, 2023
    Date of Event
    October 16, 2023
    Report Date
    October 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 ADDITIONAL INFORMATION: THE PROCEDURE WAS A LEFT HEPATECTOMY IN THE LEFT LOBE OF THE LIVER. WHEN THE BLEEDING COMPLICATION OCCURRED, THE SURGEON WAS PERFORMING A LIVER RELEASE AND DISSECTION OF THE HEPATIC HILUM LYMPH NODES. IT WAS NOTED THAT THE HEPATIC RELEASE AND DISSECTION OF THE HEPATIC HILUM LYMPH NODES HAD BEEN COMPLETED PRIOR TO THE BLEEDING COMPLICATION OCCURRING. THE TRANSECTION OF THE LIVER WAS THE PLANNED NEXT STEP.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE SYSTEM LOG FOR THE REPORTED PROCEDURE FOUND NO RELEVANT SYSTEM ERRORS. REVIEW OF THE 3 SUBSEQUENT PROCEDURES PERFORMED WITH SYSTEM ALSO FOUND NO ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. REVIEW OF THE INSTRUMENT LOGS FOUND THAT THE FOLLOWING MULTIPLE USE INSTRUMENTS WERE USED DURING THE PROCEDURE AND A SITE REVIEW FOUND NO REPORTED COMPLAINTS: 30-DEGREE ENDOSCOPE PLUS, MARYLAND BIPOLAR FORCEPS, CADIERE FORCEPS, HARMONIC ACE, MONOPOLAR CURVED SCISSORS. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE PATIENT WAS NEARING COMPLETION OF A PARTIAL HEPATECTOMY WHEN THERE WAS SIGNIFICANT BLEEDING FROM AN UNCONFIRMED SOURCE. AS A RESULT OF THE INJURY, THE PATIENT HAD A CATASTROPHIC BLEEDING EVENT AND EXPIRED. NO ALLEGATION OF ANY INTUITIVE SURGICAL PRODUCTS HAS BEEN MADE. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DONOR PARTIAL HEPATECTOMY PROCEDURE, THE PATIENT EXPIRED. THE PROCEDURE WAS NEARING COMPLETION WHEN HEAVY BLEEDING STARTED AND THERE WAS AN IMMEDIATE CONVERSION TO LAPAROTOMY. THE ORIGIN OF THE BLEEDING WAS THE HEPATIC PORTAL VEIN AND/OR THE INFERIOR CAVA. CAUTERY AND SUTURING WERE PERFORMED TO CONTROL THE BLEEDING. THERE WAS APPROXIMATELY 2L OF BLOOD LOSS. THE PATIENT RECEIVED ¿COUNTLESS¿ BAGS OF PACKED RED BLOOD CELLS AND PLASMA. THE PATIENT PROGRESSED TO CARDIO-RESPIRATORY ARREST AND AFTER APPROXIMATELY ONE HOUR OF UNSUCCESSFUL ATTEMPTS AT RESUSCITATION THE PATIENT EXPIRED. THE REPORT SOURCE STATED THAT THERE WAS NO PRODUCT QUALITY DEVIATION CONSIDERED; THE ROBOTIC SYSTEM REMAINS IN USE WITH NO REPORTS OF ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238139 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-41 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES