BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20748038 · Received November 21, 2024

    Report

    Report Number
    2955842-2024-22249
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 1, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO ERRORS C-38 AND C-37. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE IESU, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED, AND THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. NO ISSUES WERE FOUND DURING VISUAL INSPECTION. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. IN ADDITION, A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE ISI TECHNICAL SUPPORT ENGINEER (TSE). THE TSE IDENTIFIED HIGH FREQUENCY CURRENT ERRORS 25913 (C-37 & C-38). THE PROBABLE ROOT CAUSE OF THE REPORTED ERRORS CAN BE ATTRIBUTED TO AN ELECTRICAL/FIBER OPTIC ISSUE ON A COMPONENT OF THE IESU. THIS ISSUE IS CAPTURED IN THE IS4000 FAMILY SHARED CLINICAL RISK ANALYSIS (818001-45) VIA RISK ID G4-SYS-70289.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU)/ERBE ERROR C-38 OCCURRED WHEN FIRED MONOPOLAR COAG. MONOPOLAR CUT WAS WORKING. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED TO REBOOT THE SYSTEM, CUSTOMER DID IT, BUT C-38 AND C-37 OCCURRED AGAIN. THE SURGERY WAS CONTINUED WITH AN EXTERNAL ESU. INTUITIVE SURGICAL, INC. (ISI) I FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY WAS COMPLETED USING FT-10. THERE WAS NO PARTICULAR IMPACT ON THE PATIENT, AND THERE WAS NO IMPACT ON THE DOCTOR OR MEDICAL STAFF.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970609 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.