BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 22045722 · Received May 19, 2025

    Report

    Report Number
    2955842-2025-20677
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 21, 2025
    Report Date
    April 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REVIEWED THE LOGS FOR THE SYSTEM ASSOCIATED WITH THE REPORTED EVENT AND WITH THE PROVIDED EVENT DATE. NO UNUSUAL SYSTEM ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, WHILE TRANSECTING THE INFUNDIBULOPELVIC (IP) LIGAMENT AND ASSOCIATED VESSELS, THE SYSTEM PRODUCED A NON-RECOVERABLE FAULT AND AUTOMATICALLY RESTARTED THE SYSTEM WITHOUT PROMPTING THE SITE TO RESTART. THERE WERE NO ERROR MESSAGES PRODUCED. THE EVENT OCCURRED DURING A CRITICAL TIME, AND DUE TO THE RESTART, IT CAUSED A DELAY IN CONTROLLING BLEEDING, CONTRIBUTING TO INCREASED UNEXPECTED BLOOD LOSS. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE OF THE BLEEDING, THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE COMPLICATION, AND WHAT SPECIFIC MEDICAL INTERVENTION WAS RENDERED DUE TO THE BLEEDING. ONCE THE SYSTEM RESTART WAS COMPLETED, THE BLEEDING WAS CONTROLLED; THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142064 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES