BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 24478268 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14657
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 27, 2026
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE INTRAOPERATIVE SYSTEM LOGS FOUND THE SYSTEM FUNCTIONED NORMALLY WITH NO ERRORS LOGGED AND NO INDICATIONS RELATING TO THIS EVENT. LOG REVIEW OF THE FIVE SUBSEQUENT PROCEDURES FOUND THE SYSTEM FUNCTIONED NORMALLY; NO INTRAOPERATIVE EVENTS OR ISSUES WERE FOUND. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 0 DEGREE ENDOSCOPE PLUS, LARGE CLIP APPLIER, MONOPOLAR CURVED SCISSORS, MEDIUM-LARGE CLIP APPLIER, LARGE NEEDLE DRIVER, CADIERE FORCEPS, FENESTRATED BIPOLAR FORCEPS, VESSEL SEALER EXTEND (VSE), SUREFORM 45 STAPLER, SUREFORM 60 STAPLER. A SITE HISTORY REVIEW FOUND NO COMPLAINTS WERE MADE FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A REVIEW OF THE SUREFORM STAPLER AND VSE LOGS SHOWED THERE WERE NO ERRORS THAT WOULD BE RELATED TO THE EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE DURING A TRANSTHORACIC ESOPHAGECTOMY PROCEDURE, AN UNDEFINED INJURY TO THE AORTA OCCURRED WHICH LED TO A PATIENT DEATH. ALTHOUGH THERE IS NO ALLEGATION AGAINST ANY INTUITIVE SURGICAL INC. (ISI) PRODUCT AND THE SURGEON STATED NO ISI INSTRUMENT CONTRIBUTED TO THIS EVENT, HOW THIS INJURY OCCURRED IS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS PROCEDURE, AN INTRAOPERATIVE COMPLICATION RESULTED IN AN AORTIC INJURY AND SIGNIFICANT HEMORRHAGE. THE BLEEDING OCCURRED WHILE PLACING A DRAIN IN THE THORACIC CAVITY AT THE CONCLUSION OF THE THORACIC PORTION OF THE PROCEDURE. THE PROCEDURE APPROACH WAS CONVERTED TO THORACOTOMY TO CONTROL THE BLEEDING. DESPITE INTERVENTION, THE PATIENT EXPERIENCED CARDIAC ARREST AND EXPIRED INTRAOPERATIVELY. THE ESTIMATED BLOOD LOSS WAS NOT PROVIDED; HOWEVER, AN UNSPECIFIED AMOUNT OF BLOOD PRODUCTS WERE TRANSFUSED. ACCORDING TO THE SURGEON, THEY DID NOT KNOW EXACTLY HOW THE INJURY TO THE AORTA OCCURRED. THE CAUSE OF DEATH WAS CARDIAC ARREST DUE TO HEMORRHAGE. THE SURGEON REPORTED THAT THE EVENT WAS NOT DUE TO A MALFUNCTION OF THE ROBOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545005 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R DA VINCI INSTRUMENTS AND ACCESSORIES