BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 20932038 · Received December 13, 2024

    Report

    Report Number
    2955842-2024-23240
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 20, 2024
    Report Date
    November 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT ASSOCIATED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). HOWEVER, FA IS NOT COMPLETE.

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS PLACED ON THE SURGEON SIDE CONSOLE AND RUN IN NORMAL MODE. THE MEASUREMENT VALUE FOR HF VOLTAGE WAS TOO SMALL. THERE WERE ALSO C-34 ERRORS DURING STARTUP AND MONO COAG ACTIVATION. THE IESU ALSO HAD A COVER BENT OUTWARD ON THE SIDE LEADING TO A GAP IN THE BACK. REMOTEFE LOGS ALSO CONFIRMED C-34 AND C-38 ERRORS ON (B)(6) 2024. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE COMPONENT. THE IESU TRIGGERED ERROR C-34 RELATED TO LOW MEASUREMENT VALUES FOR THE HF VOLTAGE. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) KEPT GIVING AN ERROR WHEN TRYING TO ACTIVATE MONOPOLAR ENERGY. THE CALLER STATED THAT THEY HAD POWER CYCLED THE IESU AND SYSTEM, BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ISSUE. THE TSE CONFIRMED WITH THE CUSTOMER THAT AN EXTERNAL GENERATOR WAS NEAR THE VISION SIDE CART (VSC). THE TSE HAD THE CUSTOMER TURN OFF THE EXTERNAL GENERATOR, BUT THE ISSUE WAS NOT RESOLVED. THE TSE ALSO CONFIRMED WITH THE CUSTOMER THAT THE IESU WAS PLUGGED INTO A DEDICATED WALL POWER OUTLET. THE PROCEDURE WAS COMPLETING AS PLANNED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858415 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-10 N/A 00886874115343

    Patients

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