BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20292707 · Received September 24, 2024

    Report

    Report Number
    2955842-2024-19491
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. HOWEVER, THE FSE IDENTIFIED THAT THE LEFT MASTER TOOL MANIPULATOR (MTM) WAS NOT BE SEATED CORRECTLY. THE MTM WAS RECALIBRATED; THERE WAS NO PART REPLACEMENT NEEDED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. DUE TO INSUFFICIENT PROCEDURAL INFORMATION, FURTHER SYSTEM/INSTRUMENT LOG INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY PROCEDURE, THE LEFT MASTER TOOL MANIPULATOR (MTM) WAS STIFFER THAN THE RIGHT MTM. THE SURGEON COULD NOT WORK WITH THAT AND SWAPPED THE SURGEON SIDE CONSOLE (SSC). THE SURGERY WAS FINISHED SUCCESSFULLY. HOWEVER, DURING FOLLOW UP WITH THE INITIAL REPORTER, IT WAS LEARNED THAT DURING THE MTM ISSUE, THE "LEFT ARM" SUDDENLY WENT UP UNCONTROLLABLY WHICH LED TO A BLEED THAT WAS LATER MANAGED AND THERE WAS A 30-45 MINUTE DELAY. THE FOLLOWING INFORMATION IS UNKNOWN: THE ESTIMATED BLOOD LOSS VOLUME ASSOCIATED WITH THE COMPLICATION, WHAT SPECIFIC MEDICAL INTERVENTION WAS RENDERED DUE TO THE BLEED, AND WHAT SURGICAL TASK THE SURGEON WAS ATTEMPTING TO PERFORM WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017037 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES