BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23868527 · Received December 22, 2025

    Report

    Report Number
    2955842-2025-49497
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    January 20, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BECAUSE THE ROTATION LIMIT HAD BEEN REACHED, THE ARM COULD NOT MOVE ANY FURTHER AND IT COULD ONLY MOVE IN THE OPPOSITE DIRECTION. THE OPERATION FROM SURGEON SIDE CONSOLE (SSC) CAUSED IT TO MOVE IN THE SAME DIRECTION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER ROTATED THE UNIVERSAL SURGICAL MANIPULATOR (USM1) TO THE OPPOSITE DIRECTION. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND PHONE SUPPORT DETAILS. A MESSAGE, "ARM1 IS AT A ROTATION LIMIT", WAS INDICATED ON USM1; HOWEVER, IT IS UNCERTAIN IF THE USM MOVED ON ITS OWN. THE PHONE SUPPORT DETAILS DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT NON-INTUITIVE MOTION OCCURRED WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THERE WAS A MESSAGE STATING THAT USM 1 WAS AT ITS ROTATIONAL LIMIT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745493 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-57 N/A 00886874110720

    Patients

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