BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24106148 · Received January 17, 2026

    Report

    Report Number
    2955842-2026-01700
    Event Type
    Malfunction
    Date Received
    January 17, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 EVENT. FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE 230 VOLT POWER CORD TO RESOLVE THE ISSUE. SYSTEM WAS TESTED AND VERIFIED READY FOR USE. THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS OBTAINED FROM QUALITY ENGINEER (QE) INVESTIGATION RESULTS: THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM A ROUGH HANDLING. CORRECTION(S): ANNEX C - INV FINDINGS DESC 1 WAS UPDATED TO: C0706. ANNEX D - CONCLUSION DESC 1 WAS UPDATED TO: D11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE ERBE POWER CABLE WAS BROKEN. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99756 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-64 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1