BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17688062 · Received September 6, 2023

    Report

    Report Number
    2955842-2023-18238
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HIGH-RESOLUTION STEREO VIEWER (HRSV) WAS ANALYZED AND FOUND THAT THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. FAILURE ANALYSIS INSTALLED MONITOR TO XI SYSTEM AND NO IMAGE IN RIGHT EYE WHEN POWER UP SURGEON SIDE CONSOLE (SSC). THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE REPORTED FAILURE AND REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE ISI DEVICE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON CALLED IN DURING THE CASE TO REPORT THAT THE RIGHT VIDEO CHANNEL ON THE SURGEON SIDE CART (SSC) WAS BLACK. PRIOR TO THE CALL INTO TECHNICAL SUPPORT, SITE RESTARTED SYSTEM TWICE WITHOUT IMPROVEMENT. THE INTUITIVE SURGICAL INC.(ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED SURGEON TO CHECK IF BOTH VIDEO CHANNELS WERE PRESENT, WHICH WAS THE CASE. ON THE RIGHT HIGH RESOLUTION STEREO VIEWER (HRSV), NO ICONS WERE PRESENT. THE HARD POWER CYCLE OF THE SSC DID NOT RESOLVE THE PROBLEM. THE PROCEDURE WAS CONVERTED TO OPEN WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT ADDITIONAL STATING THAT ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454615 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

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