BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24551683 · Received March 9, 2026

    Report

    Report Number
    2955842-2026-15041
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 9, 2026
    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
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) INVESTIGATION IS NOT COMPLETE. THE FSE WAS ADVISED TO PERFORM READJUSTMENT/REPLACEMENT OF THE UNIVERSAL SURGICAL MANIPULATOR (USM). ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FSE ALSO CALLED THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THEY COULD CONTINUE PERFORMING SURGERIES. NO ERROR AFTER RELOCATING. THE SYSTEM WAS UP AND RUNNING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START (PRE-ANESTHESIA) OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE BY THE CUSTOMER TO REPORT THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS A BIT LOOSE AND SURGEON WAS FEELING A VIBRATION IN IT DURING SURGERY. TSE CHECKED ERROR LOGS AND THERE WAS NOTHING RELATED. TSE ASKED CUSTOMER IF THEY COULD REBOOT THE SYSTEM, WHICH WAS NOT POSSIBLE AND THEY EXPLAINED THEY WOULD CALL BACK AT THE END OF THE PROCEDURE FOR FURTHER TROUBLESHOOTING. CUSTOMER CALLED BACK AND STATED THAT WHEN THEY FINISHED THE FIRST SURGERY, THEY DID NOT HAVE TIME TO TROUBLESHOOT BECAUSE THEY HAD TO START THE NEXT ONE AND THEREFORE THE ONLY THING THEY DID WAS REBOOTING THE SYSTEM, WITH NO IMPROVEMENT. CALLER EXPLAINED THAT SINCE THEY WERE ON A RUSH, THEY DECIDED TO DO THE SECOND SURGERY IN LAPAROSCOPIC AND THAT THEY WOULD CALL BACK AT THE END OF THE SECOND SURGERY AND BEFORE STARTING THE THIRD ONE. THE PROCEDURE WAS CONVERTED PRIOR TO CALLING TSE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557176 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-37 N/A 00886874115404

    Patients

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