BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22040057 · Received May 16, 2025

    Report

    Report Number
    2955842-2025-20864
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 28, 2025
    Report Date
    April 28, 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
    TX, US
    Reporter Occupation
    003

    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 EVENT. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM), PROXIMAL SET-UP JOINT (SUJ) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE USM WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED 40067 WAS CONFIRMED AND REPLICATED. IN LOGS, THE 40067 ERROR WAS FOUND INDICATING THE AC_1A REPORTED A COMMUNICATION ERROR, CONFIRMING THE FAULT OCCURRED IN THE FIELD. AFTER FURTHER INVESTIGATION USING LOGS, ERROR 31226 WAS FOUND TO HAVE OCCURRED DURING THE SAME PROCEDURE ON ARM 3 INDICATING THAT AN AURORA LINK ERROR WAS REPORTED BY THE SUJ PROXIMAL. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM IN NORMAL MODE WHERE NO ERRORS WERE TRIGGERED. THE UNIT WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE FIBER POWER TEST FAILED, REPLICATING THE REPORTED EVENT. FIBER OPTIC CABLE WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. .

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IN EACH SYSTEM COMPONENT IS LISTED AS FOLLOWS: THE PROBABLE ROOT CAUSE FOR PROXIMAL SET-UP JOINT (SUJ) ISSUES IS ATTRIBUTED TO COMMUNICATION ERRORS FROM THE FIBER OPTICAL CABLE LOCATED WITHIN THE SUJ. THE PROBABLE ROOT CAUSE FOR UNIVERSAL SURGICAL MANIPULATOR (USM) ISSUES IS ATTRIBUTED TO COMMUNICATION ERRORS FROM THE CLOCKSPRING FIBER CABLE LOCATED WITHIN THE USM. FURTHERMORE, THE PROBABLE ROOT CAUSE FOR 2ND USM ISSUES IS ATTRIBUTED TO COMMUNICATION ERRORS FROM THE CLOCKSPRING FIBER, PARALLELOGRAM AND ROLLING LOOP CABLES LOCATED WITHIN THE USM.

    Additional Manufacturer Narrative · 0

    THE FIRST USM WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED WAS CONFIRMED AND REPLICATED. IN LOGS, THE 1126 ERROR WAS FOUND INDICATING ¿HIROSE FIBER RECEIVE POWER HAS FALLEN BELOW THE LOW WARNING LIMIT¿ ON THE USM ¿ACXC¿ AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALL ONTO A GOLDEN SYSTEM WHERE THE NO ERRORS WERE TRIGGERED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE FIBER TEST WAS FOUND TO BE FAILING ON THE ¿ACXC¿ AXIS. THE SECOND USM CAME IN FOR ERROR 1126, 31226 & 32097. THE ERRORS WERE CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED ERRORS 1126 & 31226. THE UNIT WAS ALSO TESTED ON THE PFPT AND FAILED ALL FIBER. A GOLD CLOCK SPRING PARALLELOGRAM & ROLLING LOOP WAS INSTALLED AND THE UNIT PASSED. THE ORIGINAL WAS RETURNED AND THE UNIT FAILED. UPON FURTHER INVESTIGATION, THERE WAS NO FLUID INTRUSION OR PHYSICAL DAMAGE. THE LOGS ALSO SHOWED ERRORS 1126, 31226 & 32097. THE CLOCK SPRING, PARALLELOGRAM & ROLLING LOOP ARE CONSISTENT WITH THE REPORTED EVENT AND ARE THE ROOT CAUSE OF THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED SYSTEM ENCOUNTERED A NON-RECOVERABLE FAULT. IT WAS STATED THAT THEY HAD A NON-RECOVERABLE ERROR # 40076 ON UNIVERSAL SURGICAL MANIPULATOR (USM) # 1 DURING THE PROCEDURE. PRIOR TO CONTACTING TSE, CUSTOMER POWER CYCLED THE SYSTEM AND CONTINUED WITH PROCEDURE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142696 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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