BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 18440933 · Received January 3, 2024

    Report

    Report Number
    2955842-2023-21882
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 12, 2023
    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
    LA, US
    Reporter Occupation
    003

    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 ELECTROSURGICAL UNIT (IESU) DUE TO MULTIPLE GROUNDING ISSUES TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. AFTER CONNECTING INSTRUMENTS INTO THE IESU, THE NEUTRAL PORT WAS NOT WORKING, AN ERROR M-0B-31 CAME UP INDICATING A DEFECTIVE INTERNAL COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, CUSTOMER REPORTS, EXPERIENCING A CHECK NEUTRAL ELECTRODE CONNECTION AND M-0B ERROR. THE CUSTOMER STATED THAT THE GROUNDING PAD WAS WORKING AT THE BEGINNING OF THE PROCEDURE, BUT THEN TURNED RED. PRIOR TO CALLING IN THE ISSUE, THE SITE TRIED DIFFERENT GROUNDING PADS AND CLEANING THE AREA WITH NO CHANGE. THE SITE TRIED FOUR GROUNDING PADS. THE SITE ALSO TRIED REBOOTING THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) PRIOR TO CALLING IN THE REPORTED ISSUE. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO PERFORM A HARD REBOOT ON IESU WITH NO CHANGE. THE SITE REPOSITIONED THE GROUNDING PAD WITH NO CHANGE. THE NURSE WAS ALSO UNABLE TO GROUND THE IESU ON HER ARM AS WELL. THE CUSTOMER STATED THAT SITE DID NOT HAVE ENERGY ACTIVATION CABLE TO CONNECT A FORCE TRIAD GENERATOR. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559186 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-06 N/A 00886874115343

    Patients

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