BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19624804 · Received June 27, 2024

    Report

    Report Number
    2955842-2024-16328
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 3, 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
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND FOUND TO HAVE ERRORS IN THE LOGS. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT PASSED. THE USM WAS TESTED ON A PFTP WHERE IT PASSED. ERRORS 23062, 23008, AND 1173 WERE CONFIRMED, BUT NOT REPLICATED. THE CARRIAGE INSTRUMENT STERILE ADAPTOR (ISA) PRINTED CIRCUIT ASSEMBLY (PCA), GEARBOX AND ROTOR ASSEMBLY FOR DOF 9, AND DOF 9 STATOR WILL BE REPLACED AS A PRECAUTION TO THE REPORTED PROBLEM. THE CARRIAGE ISA PCA, GEARBOX AND ROTOR ASSEMBLY FOR DOF 9, AND DOF 9 STATOR WILL BE SAVED FOR ENGINEERING. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, BUT NOT DURING FAILURE ANALYSIS.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE ISI FSE REPLACED THE USM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM A FAILURE ANALYSIS. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    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-BENIGN SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THE SITE STILL EXPERIENCED FAULTS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE CUSTOMER STATED THEY WERE UNABLE TO RECOVER THE ERROR AND THE SITE WAS UNABLE TO MOVE USM 4 FAR ENOUGH AWAY FROM THE COLUMN TO MOVE TO BOOM AND ELECTED TO CONVERT TO LAPAROSCOPIC SURGERY. ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO TROUBLESHOOT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CONVERSION DID RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PATIENT TOLERATED THE CHANGE (CONVERSATION OF PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712087 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.