BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21100412 · Received January 8, 2025

    Report

    Report Number
    2955842-2025-00204
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 13, 2024
    Report Date
    December 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE E-100 GENERATOR WAS ANALYZED AND FOUND THAT THE REPORTED COMPLAINT COULD NOT BE REPLICATED. THIS UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND MANUALLY POWER CYCLED 10 TIMES. THE E-100 POWERED ON WITH NO ISSUE EACH TIME. A VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS INSTALLED ONTO THE UNIT WITH A SALINE DIPPED GAUZE IN THE JAWS. E-100 WAS FIRED WITH YELLOW PEDAL/SYNC ACTIVATION AND CUT/SEAL ABOUT 100 TIMES. ADDITIONALLY, THE VSE WAS USED TO ATTEMPT MANY TIMES TO PROMPT ENERGY ERROR MESSAGES BY GRABBING TOO LITTLE OR TOO MUCH GAUZE. THE UNIT SHOWED NO TROUBLE SOUNDING WARNING TONES AND THE SYSTEM PRESENTED A MESSAGE TO CORRECT EACH TIME. UNIT PASSED VISUAL INSPECTION. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW FOR SYSTEM INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE OF THIS ISSUE IS ATTRIBUTED TO ELECTRICAL OR FIBEROPTIC DEFECTS RELATED TO A E-100 GENERATOR COMPONENT OR MODULE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE E-100 GENERATOR 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 CONFIRMED BASED ON THE FIELD 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE BIPOLAR WAS NOT MAKING THE WARNING BEEP WHEN GRASPING TOO LITTLE TISSUE. THE TSE REVIEWED ONSITE LOGS WHICH SHOWED ERROR 25913 (M-12) ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). TSE INSTRUCTED CUSTOMER TO REBOOT THE IESU AND THEY DID. THE STAFF WAS UNABLE TO SEE IF THAT WORKED AS THE DOCTOR DIDN'T NEED TO USE ENERGY AT THIS TIME. STAFF WAS PROCEEDING WITH THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106087 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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