BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17565013 · Received August 17, 2023

    Report

    Report Number
    2955842-2023-17810
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 21, 2023
    Report Date
    July 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM BY THE CUSTOMER OF BEING UNABLE TO DRAPE USM 1, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATION THE CUSTOMER REPORTED ISSUE. THE FSE WAS ABLE TO REPLICATE THE ISSUE AND REPLACED THE USM. THE FSE THEN TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE USM FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL B SUBMITTED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. A VISUAL INSPECTION WAS DONE AND NOTICED THE CENTER PRESENCE PIN WAS PUSHED DOWN. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITH NO TRIGGERED ERRORS. THE USM WAS ALSO TESTED ON AN IN-HOUSE SYSTEM WHERE IT PASSED CARRIAGE SWITCH, CARRIAGE STRENGTH, AND CARRIAGE FRICTION TESTS.

    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 FOLLOWING PARTS WERE REPLACED TO RESOLVE THE PROBLEM STERILE ADAPTER NOT FITTING ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. USM1 SYSTEM TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. SYSTEM VERIFIED AND READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS ANALYZED AND FOUND TO HAVE ONE OF THE MIDDLE STERILE ADAPTER PRESENCE PINS WAS STUCK DOWN AND HAD A LOT OF FRICTION WHICH WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE STERILE ADAPTER PRESENCE PINS WERE VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE CARRIAGE PRESENCE PINS WERE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO START A DA VINCI-ASSISTED TRANSVERSE COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO DRAPE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AS THE STERILE ADAPTER WOULD NOT CLICK ON THE USM. THE CUSTOMER POWER CYCLED THE SYSTEM AND EMERGENCY POWER OFF (EPO)'D THE PATIENT SIDE CART( PSC), STILL THE ISSUE PERSISTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO ISSUES IN THE SYSTEM LOGS. THE CUSTOMER ALSO TRIED 3 DIFFERENT DRAPES ON THE USM 1; HOWEVER, THE ISSUE PERSISTED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE ROBOTICALLY USING 3 USMS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198437 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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