BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19092781 · Received April 11, 2024

    Report

    Report Number
    2955842-2024-13077
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 12, 2024
    Report Date
    March 18, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    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 FSE OBSERVED REPEATED VIO DV INTEGRATED ELECTRO SURGICAL UNIT (IESU) ERRORS C-54 AND C-34; ERROR C-34 IS AN ERBE ERROR WHICH INDICATES A LOWER VOLTAGE THAN EXPECTED. THE FUSE AND VOLTAGE SETTING WAS CHECKED. THE FSE REPLACED A FUSE BUT THE ISSUE PERSISTED. THE FSE REPLACED THE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU AND PERFORMED FAILURE ANALYSIS (FA) EVALUATION. FA WAS ABLE TO REPRODUCE AND CONFIRMED THE CUSTOMER REPORTED ISSUE. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND RAN IN NORMAL MODE. THE UNIT WAS TO BE REPAIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED THYROIDECTOMY PROCEDURE, MULTIPLE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERRORS OCCURRED. THE FUNCTIONALITY WAS CHECKED PRIOR TO STARTING THE PROCEDURE, AND THERE WERE NO ISSUES. THE ERROR OCCURRED SHORTLY AFTER THE PROCEDURE BEGAN. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY AND COMPLETED; BUT THE PATIENT EXPERIENCED POST OPERATIVE BLEEDING. THE FOLLOWING INFORMATION IS UNKNOWN: IF ANOTHER ELECTRO SURGICAL UNIT (ESU) WAS USED, WHY THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY, THE CAUSE AND SOURCE OF THE BLEEDING, THE SEVERITY OF THE BLEEDING, THE ESTIMATED BLOOD LOSS, WHEN THE POST-OPERATIVE BLEEDING WAS IDENTIFIED, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334302 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 00886874110720

    Patients

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