BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21999370 · Received May 10, 2025

    Report

    Report Number
    2955842-2025-20128
    Event Type
    Malfunction
    Date Received
    May 10, 2025
    Date of Event
    April 21, 2025
    Report Date
    April 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR -RIGHT (MTMR) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN LOG REVIEW, THE MTMR WOULD NOT HOME WAS NOTED BY THE FSE CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, IT WAS DETECTED THAT THE GEAR CLAMP HAD DROP OUT OF POSITION CAUSING THE FLEX BELTS TO GET TWISTED UP. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO THE FLEX E BELTS PER REPLICATION AND CONFIRMATION OF THE CUSTOMER-REPORTED ISSUE DURING FA. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE CONVERTED TO LAPAROSCOPIC, AND PROCEDURE CONVERTED TO OPEN. THE PORT INCISION HAD TO BE INCREASED. THERE WAS NO NEED TO PLACE ADDITIONAL PORTS. OPEN INCISION VS MIS INCISION.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE, THE SYSTEM PASSED THE GRAVITY TEST AND ALL TESTING. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, SITE RECEIVED A SYSTEM MESSAGE STATING THAT THERE WAS AN OBSTRUCTION WITH HAND CONTROL. SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). SITE CONFIRMED THAT THERE WAS NO OBSTRUCTION. TSE HAD SITE PERFORM HARD POWER CYCLE THE SYSTEM, BUT THE ISSUE WAS NOT RESOLVED. TSE CONFIRMED SEVERAL 22005 ERRORS POINTING TO MASTER TOOL MANIPULATOR RIGHT (MTMR) IN THE LOGS. AFTER, SITE SHUT DOWN THE SYSTEM AND EXERCISE MTMR, BUT THE MTMR WOULD NOT HOME. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328494 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-08 N/A 00886874110744

    Patients

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