BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21041480 · Received December 30, 2024

    Report

    Report Number
    2955842-2024-23779
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 4, 2024
    Report Date
    December 4, 2024
    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
    MA, US
    Reporter Occupation
    NURSE
    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 EVENT. THE FSE PERFORMED TROUBLESHOOTING AND OBSERVED A LOOSE/WEAK FIBER CABLE CONNECTION. THE FSE ALSO REPLACED THE PROXIMAL SET-UP JOINT (SUJ) AND DISTAL SUJ. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE UNITS; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONFIRMED THE ERROR 319 WAS PERSISTENT AT STARTUP. THE FSE USED THE FIBER JUMPER KIT AND TESTED FROM THE FURTHEST TWO CONNECTIONS AND WORKED INWARD. ONCE THE FSE WORKED UNTIL THE CLOCK SPRING WAS BEING JUMPED THE FSE RECONNECTED ALL ORIGINAL FIBER CABLES AND THERE WERE NO ERRORS. THE FSE CHECKED BOTH GIGABIT COMM STATUS AND AURORA COMM LINK AND FOUND NO ERRORS. THE FSE RAN THE ROBOT THROUGH ITS FULL ROM AT ALL AXIS AND HAD NO ERRORS. FSE ATTRIBUTES THE ISSUE TO A LOOSE/ WEAK FIBER CONNECTION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. ISI RECEIVED THE PROXIMAL SET-UP JOINT (PSUJ) AND DISTAL SET-UP JOINT (DSUJ) FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WERE ANALYZED, AND THE FOLLOWING INVESTIGATIONS WERE OBTAINED: PROXIMAL SET-UP JOINT: THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED PROBLEM WAS CONFIRMED BUT NOT REPLICATED. PROXIMAL WAS RETURNED WITH DISTAL (SN: 443732). IN ARTEMIS, ERROR 307 WAS CONFIRMED ON THE ACU, INDICATING THE NODE FAILURES OCCURRED AFTER STARTUP. ERRORS 319 OCCURRED ON THE DISTA AND USM DURING NEXT POWER CYCLES, INDICATING NODES WERE NOT PRESENT AT STARTUP. INSTALLED BOTH PROXIMAL AND DISTAL ONTO GOLDEN SYSTEM WHERE N FAULTS OCCURRED IN NORMAL MODE. TESTED PROXIMAL ON PFTP WHERE IT PASSED ALL TESTING. AFTER TESTING WAS COMPLETE, VISUAL INSPECTION FOUND NO FAULTS RELATED TO THE REPORTED EVENT. DISTAL SET-UP JOINT: THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED PROBLEM WAS CONFIRMED BUT NOT REPLICATED. IN ARTEMIS, ERROR 319 AND 307 WERE CONFIRMED, INDICATING NODE COMMUNICATION FAILURES. HOWEVER, DISTAL WAS FOUND TO BE FAULTING PRIOR TO THIS INSTANCE, WITH ERRORS 32115 AND 320 INDICATING HARDWARE FAULTS. INSTALLED DISTAL ONTO GOLDEN SYSTEM IN NORMAL MODE WHERE NO FAULTS OCCURRED. TESTED DISTAL ON PFTP WHERE IT PASSED A RELEVANT TESTING. AFTER TESTING WAS COMPLETED, VISUAL INSPECTION FOUND FAULTS RELATED TO THE REPORTED EVENT. THE PROBABLE ROOT CAUSE OF ERROR 319 MAY BE ATTRIBUTED TO A FAULTY SYSTEM COMPONENT. WHEN COMMUNICATION THROUGH THIS COMPONENT IS INTERRUPTED, THE SYSTEM IS PLACED IN AN UNRECOVERABLE SOFT-LOCK MODE AND THIS ERROR CAN BE RESOLVED WITH A POWER CYCLE AND RECONNECTION OF THE BLUE FIBER CABLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING A NON-RECOVERABLE FAULT OCCURRING ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE CUSTOMER HAD PERFORMED A POWER CYCLE, AND THE SYSTEM POWERED BACK ON WITH RECOVERABLE FAULTS. THE TSE REVIEWED THE LOGS AND FOUND ERROR 319 ON USM 2. THE TSE SUGGESTED TO PERFORM AN EMERGENCY POWER OFF ON THE PATIENT SIDE CART. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418335 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.