BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19038521 · Received April 3, 2024

    Report

    Report Number
    2955842-2024-12966
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 11, 2024
    Report Date
    March 11, 2024
    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
    NL
    Reporter Occupation
    NURSE
    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 UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED. LOGS CONFIRMED THE ERROR 22020 BUT WAS NOT REPLICATED IN-HOUSE. UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. UNIT RECOGNIZED AND PASSED THE FOLLOWING INSTRUMENT TEST: LARGE NEEDLE DRIVER, FENESTRATED BIPOLAR FORCEPS, CAMERA, AND STAPLER 45. UNIT WAS TESTED ON PFTP AND IT PASSED ALL TEST. THE COMPLAINT WAS CONFIRMED BASED ON 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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE USM; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION OR IF ADDITIONAL INFORMATION IT OBTAINED.

    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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM)4 WAS SOMETIMES SIGNALING YELLOW, OR THE INSTRUMENT TIP COULDN'T BE MOVED PROPERLY. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) DID NOT SEE ERRORS IN LIVE LOGS POINTING TO A PROBLEM WITH USM 4 BUT FOUND ERRORS 1169 AND 31009 POINTING TO CANNULA/INSTRUMENT SENSORS ON USM4. THE OR STAFF RESEATED STERILE ADAPTER (SA), USED DIFFERENT INSTRUMENTS ON USM 4 AND POWER CYCLED SYSTEM WHICH DID NOT SOLVE THE PROBLEM. WHEN THE INSTRUMENT FROM USM 4 WAS INSTALLED ON ANOTHER USM, THERE WERE NO PROBLEMS. THE TSE ADVISED THE CUSTOMER TO CHECK INSTRUMENT/SA SENSING PINS AND POGO PINS. THE TSE SUGGESTED CALLER TO PUSH THE EMERGENCY STOP AND PERFORM FAULT OVERRIDE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018383 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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