BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 24312806 · Received February 11, 2026

    Report

    Report Number
    2955842-2026-03233
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 14, 2026
    Report Date
    March 14, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED ENERGY SHIELD MONITOR (ESM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE LOGS, ERRORS WERE FOUND INDICATING THE ESM WAS NOT PRESENT, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM AND FUNCTIONED AS EXPECTED.

    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 SYSTEM DISPLAYED AN INSULATION ERROR MESSAGE. THE FSE WENT ON SITE AND IDENTIFIED RESIDUE ON THE CORDS FOR THE EXISTING ENERGY SHIELD MONITOR (ESM). THERE WAS ALSO RESIDUE ON THE CORNERS OF THE ERBE SCREEN, POSSIBLY DUE TO A BAD PART OR STAFF WAS UTILIZING A CORROSIVE WIPE FOR CLEANING. THE FSE REPLACED THE ESM TO RESOLVE THE ISSUE WITH THE RE-OCCURRING INSULATION ERROR MESSAGE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS STILL PENDING. .

    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 ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER TRIED 4-5 TIPS AND SHEATHS BUT THE CORD LIGHT ON THE EMBEDDED SERIALIZER FOR MASTER (ESM) WAS AMBER, AND THEY WERE RECEIVING A MESSAGE TO REMOVE THE TIP AND INSTALL A NEW SHEATH. PRIOR TO CALLING, THE CUSTOMER HAD REPLACED THE TIP AND INSTRUMENT ON THE MONOPOLAR CURVED SCISSORS (MCS) MULTIPLE TIMES AND TRIED FIVE DIFFERENT INSTRUMENTS, WITH NO CHANGE. THE CUSTOMER NOTED THAT THEY HAD USED THE INSTRUMENT IN DIFFERENT DRIVES, ALSO WITH NO CHANGE, BUT HAD NOT REPLACED THE CORD. THE TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THEY REPLACE THE MONOPOLAR ENERGY CORD WHICH THE USER PERFORMED WITH NO CHANGE. THE USER THEN POWERED OFF THE ERBE GENERATOR AND ENERGY SHIELD MONITOR (ESM) AND THE SYSTEM FAULTED AND THE CALLER POWER CYCLED THE SYSTEM TO RESTORE ESM FUNCTIONALITY. THE TSE WALKED THE CALLER THROUGH RESEATING THE GROUND CONNECTOR AND GREEN MONOPOLAR CABLE CONNECTOR TO ANOTHER MONOPOLAR RECEPTACLE ON THE FRONT OF THE ERBE WITH NO CHANGE. THE CALLER THEN USED A 3RD MONOPOLAR GREEN/GRAY ENERGY CABLE FROM THE ESM TO THE INSTRUMENT WITH NO CHANGE. THE CUSTOMER THEN CONVERTED FROM SINGLE PORT (SP) TO MULTI-PORT XI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238672 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-34 N/A 00886874114742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES