BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20976176 · Received December 19, 2024

    Report

    Report Number
    2955842-2024-23385
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 25, 2024
    Report Date
    November 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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) OR ERBE WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED (MONOPOLAR NOT FIRING) ERROR WAS CONFIRMED BUT NOT REPLICATED. IN ERROR LOGS, THE (M-36) ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UP VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. AS A SAFETY PRECAUTION THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) TO DETERMINE THE ROOT CAUSE AND FOR FURTHER INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN ELECTRICAL COMPONENT FAILURE.

    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. SYSTEM VERIFIED AND READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD 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 PROSTATECTOMY-SIMPLE SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED MONOPOLAR ENERGY WAS NOT FIRING. PRIOR TO CONTACTING TSE, CUSTOMER TRIED TWO DIFFERENT CAUTERY CABLES AND MONOPOLAR INSTRUMENTS WITHOUT SUCCESS. CUSTOMER STATED THEY HAD A QUESTION MARK ON INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE'S PORT WHERE MONOPOLAR INSTRUMENT WAS CONNECTED. TSE REVIEWED ERROR LOGS AND FOUND ERROR "M36". TSE ASKED CUSTOMER TO CONNECT CAUTERY CABLE TO THE OTHER MONOPOLAR PORT WITHOUT SUCCESS. TSE ASKED CUSTOMER TO REMOVE ALL ENERGIZED INSTRUMENTS FROM PATIENT SIDE CART (PSC) AND CAUTERY CABLES FROM ERBE WITHOUT SUCCESS. TSE ASKED CUSTOMER TO INSTALL MONOPOLAR INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM1) INSTEAD OF USM4 WITHOUT SUCCESS. TSE ASKED CUSTOMER TO TRY A THIRD CAUTERY CABLE WITHOUT SUCCESS. TSE ASKED CUSTOMER TO TRY A THIRD MONOPOLAR INSTRUMENT WITHOUT SUCCESS. TSE ASKED CUSTOMER TO VERIFY ERBE CONNECTION WITH VIDEO PROCESSOR AND SHE STATED IT WAS PROPERLY CONNECTED. TSE ASKED CUSTOMER WHETHER THEY HAD A FORCE TRIAD, AND THEY HAD IT. THEY WERE NOT ABLE TO FIND ACTIVATION CABLE. SURGEON TRIED MONOPOLAR ENERGY WITH FORCE TRIAD AND ITS EXTERNAL PEDALS AND CUSTOMER STATED IT WAS NOT DELIVERING ENOUGH ENERGY. THEY DECIDED TO CONTINUE THE PROCEDURE USING SYNCHROSEAL INSTRUMENT INSTEAD OF MONOPOLAR CURVED SCISSORS (MCS). THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE COMPLETED ROBOTICALLY USING SYNCHROSEAL (E100) AND BIPOLAR ENERGY (ERBE). THE TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED BY THE SURGEON WAS PROSTATECTOMY. THE PROCEDURE BEGAN AT 3:20 PM ON (B)(6) 2024. MONOPOLAR ENERGY WAS NOT AVAILABLE FOR THE ENTIRETY OF THE PROCEDURE; THEY USED SYNCHROSEAL INSTEAD OF MONOPOLAR ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284099 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A

    Patients

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