BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20294651 · Received September 24, 2024

    Report

    Report Number
    2955842-2024-19753
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 FOUND A LOOSE CONNECTION ON J3 TO THE SURGEON BACKPLANE (SBP) FROM THE TOUCH PAD. THE ISI FSE RESEATED CONNECTION AT J3 AND AT THE TOUCH PAD AND ISSUE CLEARED. THE ISI FSE RAN THROUGH ERGONOMICS 3X AND POWER CYCLED 5X WITH NO ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE NON-RECOVERABLE ERROR 307 WAS REOCCURRING AT EACH POWER CYCLE. THE SYSTEM LOGS CONFIRMED ERROR 307 AND 75 INDICATING THAT THE SURGEON SIDE CONSOLE (SSC) 2 TOUCH PAD CONTROLLER (TPC) 2 WAS NOT RESPONDING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED POWERING OFF AND DISCONNECTING CONSOLE 2 AND POWERING UP AS A SINGLE CONSOLE SYSTEM. THE SYSTEM POWERED ON WITHOUT ERRORS AND PROCEDURE CONTINUED WITH SSC 1 ONLY. THE SITE WAS COMPLETING THE PROCEDURE WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017169 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A 00886874110744

    Patients

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