BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 22412382 · Received July 7, 2025

    Report

    Report Number
    2955842-2025-28442
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 16, 2025
    Report Date
    June 16, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE INSUFFLATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE INSUFFLATOR; HOWEVER, THE FAILURE ANALYSIS EVALUATION HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INSUFFLATOR ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS CONFIRMED THE REPORTED EVENT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO THE KNOWN GOOD IN-HOUSE SYSTEM AND BOOTED UP WITH NO ISSUES. A VALID TUBE SET WAS INSTALLED, AND THE INSUFFLATOR ERRORED OUT FOR AN INVALID TUBE SET. THERE WAS AIR LEAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM INSUFFLATOR STOPPED WORKING DURING A MALIGNANT HYSTERECTOMY SALPINGO-OOPHORECTOMY PROCEDURE, WHICH CAUSED A RAPID LOSS OF INSUFFLATION AND LOSS OF VISION. TROUBLESHOOTING WAS ATTEMPTED, WHICH INCLUDED SWITCHING TO THE HOSPITAL GAS LINE, RESTARTING THE SYSTEM, AND REPLACING MULTIPLE INSUFFLATION TUBES, BUT THE ISSUE PERSISTED. THE DA VINCI INSUFFLATOR WAS DISCONTINUED, AND A THIRD-PARTY INSUFFLATOR WAS UTILIZED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO DIRECT PATIENT INJURY DUE TO THE LOSS OF VISION. THERE WAS A DELAY OF ROUGHLY 15-20 MINUTES DURING A CRITICAL PART OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950631 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.