BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 22000139 · Received May 12, 2025

    Report

    Report Number
    2955842-2025-20156
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 17, 2025
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS AND REPRODUCED THE ISSUE DURING IN-HOUSE TESTING. DURING POWER-ON TEST, THE C-34 ERROR WAS FOUND. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PROBABLE CAUSE OF ERRORS C-30 AND C-34 IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE IESU. THIS ERROR INDICATES A LOWER VOLTAGE THAN EXPECTED WHILE POWERED ON OR DURING ENERGY ACTIVATION.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AS VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE IESU HAS NOT YET BEEN RECEIVED BY ISI FOR 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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING THE ERBE ERROR M-11 AND C-30. PRIOR TO CALLING TSE, THE ERBE GENERATOR HAD BEEN RESTARTED, AND THE REPORTED COMPLAINT PERSISTED. TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED SEVERAL ERRORS M-11, C-06, AND C-30 POINTING TO AN INTERNAL TIMEOUT. TSE CONFIRMED THAT THERE WAS NO ENVIRONMENTAL SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI) SUCH AS MAGNETIC RESONANCE IMAGING (MRI) OR COMPUTED TOMOGRAPHY (CT) SCAN, OR ANOTHER ELECTRICAL SURGICAL UNIT (ESU) IN CLOSE PROXIMITY CREATING EXCESS EMI. THE CUSTOMER CONFIRMED THAT THERE WAS NOTHING PRESSING THE FOOT PEDALS WITHIN THE VISION SIDE CART (VSC) DRAWER. THE REPORTED COMPLAINT CAME BACK AFTER TSE GUIDED THE SURGEON TO DISCONNECT THE POWER CORD FROM THE ERBE, WAIT A MINUTE, AND RESTART THE ERBE. TSE ASKED THE CUSTOMER IF THE ERBE WAS CONNECTED TO A DEDICATED ALTERNATING CURRENT (AC) OUTLET, AND THE CUSTOMER FOUND THAT IT WAS. THE CUSTOMER RECONNECTED THE ERBE POWER CORD TO A DEDICATED AC OUTLET, BUT THE REPORTED COMPLAINT PERSISTED. THE CUSTOMER DID NOT HAVE A SPARE GENERATOR. TSE EXPLAINED TO THE CUSTOMER THAT THE ERBE WOULD NEED TO BE REQUIRED. THE SURGEON AGREED TO CONTINUE THE SURGICAL PROCEDURE USING THE BIPOLAR. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390644 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-10 N/A 00886874115343

    Patients

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