BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 8978575 · Received September 10, 2019

    Report

    Report Number
    2955842-2019-10692
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS REPLICATED BASED ON THE FIELD EVALUATION. THE VIDEO SLICE (VSL) WAS INSTALLED AND TESTED IN THE PRINTED CIRCUIT BOARD (PCA) TEST SYSTEM. THE SYSTEM START UP FAILED WITH ERROR 307. THE VSL WAS REMOVED FROM THE SYSTEM AND POWERED UP AT THE TEST BENCH. IT CAME UP WITH NO HEARTBEAT AND ALL OF THE POWER REGULATORS WERE OFF, INDICATING A POWER PROBLEM WITH THE BOARD. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE DA VINCI SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE SYSTEM HAD NON RECOVERABLE ERROR 307 ERROR POINTING TO THE VIDEO SLICE PROCESSING (VSL2). THE CUSTOMER HAD TO USE THE INSTRUMENT RELEASE TOOL KIT (IRT) TO REMOVE INSTRUMENTS THAT WERE STUCK ON TISSUE. THE SYSTEM WAS RESTARTED, AND THE ERROR RETURNED. TWO MORE HARD RESTARTS OF THE VISION SIDE CONSOLE (VSC) WERE PERFORMED WITH NO SUCCESS. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC (LAP) PROCEDURE WITH NO REPORTED INJURY. ON 8/29/2019, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE OPERATING ROOM NURSE WHO CONFIRMED THAT THE ISSUE OCCURRED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772660 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-05

    Patients

    Seq Age Sex Outcome Treatment
    1