BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 21940627 · Received May 1, 2025

    Report

    Report Number
    2955842-2025-17926
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 4, 2025
    Report Date
    June 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) QUALITY ENGINEERING (QE) TEAM PERFORMED FURTHER INVESTIGATION TO IDENTIFY THE PROBABLE ROOT CAUSE OF REPORTED ISSUE. BASED ON THE INVESTIGATION , THE PROBABLE ROOT CAUSE OF ERROR 23072 IS ATTRIBUTED TO A FAULTY SET-UP JOINT (SUJ) PROXIMAL CABLE. ANNEX C, D AND, G CODES WERE UPDATED BASED ON THE ADDITIONAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE SET UP JOINT (SUJ) 1 PROXIMAL HARNESS AND SUJ1 DRAPE MAGNET TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED.

    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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED AN ERROR 23072 WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. CALLER REPORTED THE ERROR WAS INTERMITTENT. TSE REVIEWED LOGS AND CONFIRMED THE ERROR 23072 POINTING USM 4. TSE INFORMED THAT THE ISSUE MAY RETURN, AND CUSTOMER MAY HAVE TO DISABLE THE USM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY CONTINUED USING ALL 4 ARMS, NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE PATIENT'S DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191041 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A 00886874115404

    Patients

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