BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21646540 · Received March 19, 2025

    Report

    Report Number
    2955842-2025-09676
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 21, 2025
    Report Date
    February 21, 2025
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO CONFIRM AND REPRODUCE THE ISSUE AND FOUND ERRORS 26002 AND 319 ON ARMNET 4. TO CORRECT THE ISSUE, THE BACKPLANE FIBER CABLE, PART NUMBER 372214 WAS REPLACED. THE SYSTEM PASSED ALL REQUIRED TESTS AND VERIFIED AS READY FOR USE. THE BACKPLANE FIBER CABLE IS A SCRAP ITEM AND WILL NOT BE RETURNED BACK TO ISI. A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: "26002 INDICATING THE MIDDLEMAN ON THE PCTP IN THE PSC HAD A FAILURE IN BP EXECUTION FOR USM4 ¿ BPCODE: BP_AMP_SWITCH_MANIP (THIS CAN BE CAUSED BY ARM CHAIN COMM FAILURE) AND 319 INDICATING NODE 194 IS NOT PRESENT AT STARTUP, NODE NAME: ACT IN ARMNET4 SUJ DISTAL." THE PROBABLE ROOT CAUSE OF ERROR 26002 MAY BE ATTRIBUTED TO ARM CHAIN COMMUNICATION FAILURE. THE PROBABLE ROOT CAUSE OF ERROR 319 MAY BE ATTRIBUTED TO A FAULTY SYSTEM COMPONENT.

    Additional Manufacturer Narrative · 0

    CORRECTION: FIELD G6 IN THE INITIAL MDR WAS INADVERTENTLY SET TO "5-DAY" BUT SHOULD HAVE BEEN SET TO "INITIAL/30-DAY".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM FAULTED WITH A NON-RECOVERABLE ERROR 26002 WHEN THE CUSTOMER WAS DOCKING THE PATIENT SIDE CART (PSC). THE SYSTEM PROMPTED THE CUSTOMER TO DISABLE THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 OR TO REBOOT THE SYSTEM. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER CONFIRMED THE ERRORS IN THE SYSTEM LOGS. THE CUSTOMER PERFORMED A HARD POWER CYCLE AND EMERGENCY POWER OFF OF THE SYSTEM, BUT IT POWERED BACK ON WITH AN ERROR 319. THE CUSTOMER OPTED TO SWAP IN ANOTHER PSC FOR THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FAULT OCCURRED PRIOR TO DOCKING THE SYSTEM. THE ERROR HAD NOT OCCURRED PRIOR TO THE REPORTED EVENT, THE CUSTOMER WAS ABLE TO COMPLETE THE CASE WITH A BACKUP PATIENT SIDE CART.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620396 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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