BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18228826 · Received November 29, 2023

    Report

    Report Number
    2955842-2023-20651
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER PERFORMED A SITE VISIT AND REPRODUCED THE ISSUE, INDICATING THAT MULTIPLE GROUNDING PADS WERE NOT RECOGNIZED BY THE GENERATOR. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE REPLACED ELECTRO SURGICAL UNIT (ESU) WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE UNIT WAS IN SINGLE PAD MODE AND SWITCHED TO DUAL PAD MODE. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE GROUNDING PAD LED ON THE ERBE WOULD NOT GO GREEN. PRIOR TO CALLING THE INTUITIVE TECH SUPPORT ENGINEER (TSE), THE CUSTOMER CHANGED OUT THE GROUNDING PAD SEVERAL TIMES, USING DIFFERENT GROUNDING PAD TYPES. THE CUSTOMER WAS TRYING TO USE A COVIDIEN E7507 GENERATOR, WHICH WAS VALIDATED. THE CUSTOMER ATTEMPTED TO CLEAN THE PATIENT'S SKIN WITH ALCOHOL, AND TRIED SEVERAL LOCATIONS, WITH NO CHANGE. THE TSE HAD THE CALLER PLACE THE GROUNDING PAD ON HIS FOREARM AND THE PAD LED CONTINUED TO STAY RED. THE TSE HAD THE CALLER FOLD THE PAD OVER ONTO ITSELF, AND THE PAD DID TURN GREEN. THE CUSTOMER THEN REPORTED THAT THE SYSTEM ENCOUNTERED A NON-RECOVERABLE FAULT. THE SYSTEM LOGS SHOWED IT WAS A FIBER CABLE COMMUNICATION ERROR AGAINST THE TOP PORT OF THE CORE. THE TSE WALKED THE CALLER THROUGH A HARD SYSTEM POWER CYCLE AND RESEATING THE BLUE FIBER CABLES. THE CALLER STATED THAT THE TOP BLUE FIBER CABLE (BFC) PORT WAS NOT SEATED ON THE BACK OF THE CORE. AFTER RESEATING, THE SYSTEM POWERED BACK ON NORMALLY. THE GROUNDING PAD WAS STILL NOT RECOGNIZED. THE CUSTOMER HAD A FORCE TRIAD GENERATOR; HOWEVER, THEY COULD NOT LOCATE THE ACTIVATION CABLE TO HOOK IT UP. THERE WAS NO OTHER VISION SIDE CART (VSC) AVAILABLE TO SWAP OUT, THEREFORE THE PROCEDURE WAS ABORTED AFTER STARTING. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719221 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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