BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21532181 · Received March 5, 2025

    Report

    Report Number
    2955842-2025-04361
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 5, 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
    CH
    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 REPLACED THE PERSONALITY MODULE ENERGY DEVICE (PMED) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS BEEN RECEIVED AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE ENERGY DEVICE (PMED), WAS ANALYZED AND THE REPORTED ISSUE WAS NOT CONFIRMED AND NOT REPLICATED. IN LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED THE FIELD. LOGS REPORTED: FE REPLACED THE PMED, BUT THE SITUATION REMAINED THE SAME AS BEFORE. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PMED WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE PMED. THE SYSTEM STARTED UP WITHOUT ANY ERROR. PERFORMED TEST WITH THE INSTRUMENTS, ALL PORTS ARE FULLY FUNCTIONAL AS NORMAL. ALL 3 PORTS WERE TESTED AND ENERGIZED BUT NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDE THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE PMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TUBAL REANASTOMOSIS SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE CONTROLLED. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THE GEN 11 GENERATOR COULD PASS THE SELF-TEST AND THE CUSTOMER STATED NO. THE TSE GUIDED THE SITE TO USE THE EXTERNAL FOOT SWITCH TO PASS THE SELF-TEST. THE CUSTOMER REPLIED THEY DID NOT HAVE THE EXTERNAL FOOT SWITCH. THE TSE SUGGESTED THAT THE SITE SHOULD CONTACT AN ETHICON FIELD SERVICE ENGINEER (FSE) FOR FURTHER TROUBLESHOOTING. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS NOT COMPLETED ROBOTICALLY BUT WAS CONVERTED TO ANOTHER TYPE OF PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING ANOTHER J&J ULTRASONIC KNIFE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. THE CLINICAL SALES REPRESENTATIVE (CSR) RESTARTED THE DA VINCI SYSTEM, RESTARTED THE ULTRASONIC KNIFE, ATTEMPTED TO CONNECT THE THREE ENERGY INTERFACES OF THE PERSONALITY MODULE ENERGY DEVICE (PMED) BOARD SEPARATELY, BUT THE HARMONIC ACE COULD NOT BE CONTROLLED. THE FSE CHECKED THE PMED, AND AFTER CONNECTING THE ULTRASONIC KNIFE, THE ENERGY INTERFACE STATUS INDICATOR LIGHT ON THE PMED BOARD DID NOT LIGHT UP. THE FSE REPLACED THE PMED, BUT THE HARMONIC ACE COULD NOT BE CONTROLLED. THE FSE BORROWED ANOTHER ULTRASONIC KNIFE FROM THE OPERATING ROOM PHYSICIAN, AND IT COULD BE USED NORMALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827626 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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