BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOWRIST

    MDR report key: 23789765 · Received December 12, 2025

    Report

    Report Number
    2955842-2025-48405
    Event Type
    Death
    Date Received
    December 12, 2025
    Date of Event
    June 14, 2023
    Report Date
    December 12, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE DATE OF THE PROCEDURE WAS PROVIDED. REVIEW OF THE VESSEL SEALER EXTEND LOGS FOUND THAT IT WAS INSTALLED TWICE (ONCE ON USM 3 AND ONCE ON USM 1) AND COMPLETED HOMING TWICE. THERE WERE TWO CUT EVENTS, ONE PER INSTALL. THE E100 GENERATOR LOGS SHOW 2 SEAL EVENTS, NEITHER OF WHICH RESULTED IN ERRORS. THERE WERE NO ERRORS IN THE LOGS RELATED TO THE USAGE OF THIS INSTRUMENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT DIED A FEW DAYS AFTER A PULMONARY LOBECTOMY. THE CAUSE OF DEATH AND THE EVENTS THAT LED TO THE DEATH ARE NOT PROVIDED. A VESSEL ISSUE IS ALLUDED TO AS A POTENTIAL ISSUE BUT NO FURTHER EXPLANATION OR DETAILS ARE 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 A PATIENT PASSED AWAY A FEW DAYS AFTER UNDERGOING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, WHICH WAS COMPLETED ROBOTICALLY. IN A CONVERSATION WITH SEVERAL INTUITIVE REPRESENTATIVES, A PHYSICIAN RECALLED A PATIENT DEATH FROM (B)(6) 2023 INVOLVING A VESSEL SEALER EXTEND (VSE) INSTRUMENT. THE PHYSICIAN STATED THERE WAS LIKELY NO MALFUNCTION OF THE VSE INSTRUMENT BUT COULD NOT RECALL THE DETAILS OF THE PROCEDURE. HE PROVIDED THE DATE OF THE PROCEDURE AND STATED HE WOULD REVIEW HIS RECORDS FOR ADDITIONAL DETAILS. MULTIPLE REQUESTS WERE MADE TO THE SURGEON FOR FURTHER DETAILS; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713399 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K16230420 0181 10886874115661

    Patients

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