BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24829031 · Received April 9, 2026

    Report

    Report Number
    2955842-2026-20787
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 14, 2026
    Report Date
    April 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED RESEATING THE STERILE ADAPTER AND SWAPPING THE INSTRUMENT. LATER, THE CUSTOMER CONFIRMED THAT ISSUE WAS RESOLVED AND STATED THAT THE HEAD SENSOR HAD NOT BEEN BLOCKED PROPERLY. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE SURGEON WAS UNABLE TO TAKE CONTROL OF THE ROBOTIC INSTRUMENTS AND NOTED A PATIENT INJURY. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND RECOMMENDED RESEATING THE STERILE ADAPTER ON THE DRAPE AND SWAPPING THE INSTRUMENT; HOWEVER, THESE ACTIONS DID NOT RESOLVE THE ISSUE. FURTHER INVESTIGATION DETERMINED THAT THE LOSS OF INSTRUMENT CONTROL WAS DUE TO THE SURGEON¿S HEAD NOT FULLY BLOCKING THE HIGH-RESOLUTION STEREO VIEWER (HRSV), WHICH PREVENTED THE SYSTEM FROM RECOGNIZING THE SURGEON'S PRESENCE AND ENABLING INSTRUMENT MANIPULATION. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE OF THE PATIENT INJURY, IF ANY BLEEDING OCCURRED, AND THE MEDICAL INTERVENTION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183539 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-58 N/A 00886874110720

    Patients

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