BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21497504 · Received February 28, 2025

    Report

    Report Number
    2955842-2025-04143
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: M-11 INDICATING INTERNAL TIMEOUT (CPU & SENSORS MODULE DOES NEED TOO MUCH TIME TO ENTER "READY" STATE). DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT WAS NOT PERFORMED, AS THE PRODUCT INVOLVED IS NOT MANUFACTURED BY INTUITIVE SURGICAL, INC. (ISI). THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE BASED ON GENERATOR DEFECT.

    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 INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. 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 NEPHRECTOMY SURGICAL PROCEDURE, VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU) FAILED TO DELIVER BIPOLAR ENERGY. SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). SITE COULD HEAR VIO DV IESU SOUND BUT COULD NOT GET A DESIRED COAGULATION EFFECT. SITE REPLACED CAUTERY CABLE TWICE, BIPOLAR INSTRUMENT ONCE, POWER CYCLED VIO DV IESU AND USED ANOTHER BIPOLAR PORT, BUT THE ISSUE WAS NOT RESOLVED. TSE COULD NOT FIND ANY RELATED ERROR IN THE LOGS. TSE HAD SITE USE A THIRD BIPOLAR INSTRUMENT AND INCREASE BIPOLAR EFFECT TO 7, WHICH RESOLVED THE ISSUE. HOWEVER, THE SURGEON WAS NOT COMFORTABLE WITH THE DELIVERED BIPOLAR EFFECT. TSE ADVISED SITE TO USE E-100 ESU WITH SYNCHROSEAL OR VESSEL SEALER EXTEND (VSE) FOR COAGULATION; HOWEVER, SITE REJECTED THE ADVISES. SITE USED A THIRD-PARTY ESU (FORCETRIAD) FOR BIPOLAR ENERGY AND VIO DV IESU FOR MONOPOLAR ENERGY TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403685 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A

    Patients

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