BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21198372 · Received January 21, 2025

    Report

    Report Number
    2955842-2025-00640
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 24, 2024
    Report Date
    December 24, 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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN SYSTEM LOGS, THE 22020 ERROR WAS FOUND INDICATING FAULT ON DEGREE OF FREEDOM (DOF) 6, 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 INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE DOF 6 GEARBOX WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN ENGAGEMENT ERROR FROM DOF 6 GEARBOX LOCATED WITHIN USM.

    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 FOUND THE ELEVATION BUTTON WAS NOT WORKING WHICH MADE IT NOT POSSIBLE TO ROTATE THE ARMS BOTH WAYS. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM), AND HE ALSO REMOVED THE PLASTIC PART FROM THE FINGER GRIPS DUE TO BLOCKING THE GRIPS TO CLOSE COMPLETELY. THIS MADE THE SURGEON NOT BEING ABLE TO FIRE THE ENERGY INSTRUMENTS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE USM HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    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 NEPHRECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 CURVED-TIP STAPLER DID NOT FIRE. ACCORDING TO THE NURSE, THE SURGEON WAS FOLLOWING PROCEDURE AS IT SHOULD, BUT WHEN THE SURGEON PUSHED THE BLUE PEDAL THE "READY TO FIRE" DISPLAY WAS NOT SHOWN. AT THE TIME OF THE CALL, THE STAPLER WAS NOT INSTALLED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED ON WHICH ARM THE STAPLER WAS INSTALLED. THE CALLER STATED IT WAS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE TSE ASKED IF THE SURGEON PUSHED AND HELD THE BLUE PEDAL AND KEPT THE RIGHT-HAND CONTROL CLOSED AT THE SAME TIME. THE CALLER STATED THIS WAS THE CASE AND THEY FOLLOWED THE INSTRUCTIONS FOR USE OF THE INSTRUMENT. THE CALLER STATED THEY MANAGED TO CONTINUE THE SURGERY WITHOUT THE USE OF THE STAPLER. THE TSE ADVISED THE CALLER TO TRY THE STAPLER ON ANOTHER USM IN CASE IT WAS NEEDED AGAIN SINCE THE ISSUE MAY BE RELATED TO USM 4 DUE TO THE ISSUE BEING REPORTED BEFORE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE ORIGINAL CONFIGURATION WITH ALL 4 ARMS. THERE WAS NO INJURY TO THE PATIENT. THE STAPLER WAS REPORTED AS NOT FIRING SO THEY USED A LAPAROSCOPIC CLIP APPLIER INSTEAD THROUGH THE EXISTING ROBOTIC PORT. THE CSA SPOKE WITH THE SURGEON WHO MENTIONED IT MAY HAVE ACTUALLY BEEN THE YELLOW PEDAL FROM HIS MEMORY. SYSTEM BEHAVED STRANGE AS HE WOULD CLAMP BUT WHILST PRESSING THE YELLOW PEDAL THERE WAS NO FIRING. TSE CHECKED THE LOGS OF THE SURGERY ON THAT DAY BUT DID NOT FIND ANY ERRORS POINTING TO AN ISSUE WITH THE PEDALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859704 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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