BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24750931 · Received April 1, 2026

    Report

    Report Number
    2955842-2026-20030
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 COMPLAINT. THE FSE WAS NOT ABLE TO REPRODUCE THE ISSUE; HOWEVER, THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE USM HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, THE USER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ARM 4 WAS NOT RECOGNIZING INSTRUMENTS. TROUBLESHOOTING STEPS INCLUDED CONFIRMING THAT ARM 4 WOULD NOT ENGAGE INSTRUMENTS, ALTHOUGH IT WAS UNDETERMINED IF THIS ISSUE AFFECTED ONLY ONE INSTRUMENT OR MULTIPLE INSTRUMENTS. LOGS CONFIRMED THE ENGAGEMENT FAILURE, INDICATING A POSSIBLE FAILURE WITH ARM 4 OR THE INSTRUMENT/ADAPTER. THE USER CONTINUED WITH THE PROCEDURE WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY BY MAKING ARM 4 THE NON-WORKING ARM SO THERE WAS NO DELAY IN CARE. THE PROBLEM WAS QUICKLY REMEDIED WHEN THE FIELD SERVICE ENGINEER CAME TO EXCHANGE THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304086 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1