BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17647100 · Received August 29, 2023

    Report

    Report Number
    2955842-2023-18080
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 5, 2023
    Report Date
    August 5, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 FOUND ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 AND REPLACED THE USM 3 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM/REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE USM WAS TESTED ON A PSC FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CANNULA LED TEST. INSPECTION ON THE AXES CONTROLLER SPAR CONNECTOR (ACSC) WAS PERFORMED WHERE THE FLUID INTRUSION WAS LOCATED ON THE ACSC AND FLAT FLEX CABLE'S (FFC). THE ACSC PRINTED CIRCUIT ASSEMBLY (PCA) AND FFC WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE COMPLAINT REGARDING THE REPEATED RECOVERABLE ERRORS WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THERE WAS A REPEATED RECOVERABLE 1162 ERROR ON ARM 3. THE TSE ASKED IF THE SURGEON WOULD BE WILLING TO USE 3 ARMS ONLY. THE CUSTOMER STATED THAT THE SURGEON WANTED TO USE ALL 4 ARMS. THE TSE VIEWED SYSTEM LOGS AND CONFIRMED THE 1162 ERROR, POINTING TO A CANNULA SENSOR IN UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE TSE RECOMMENDED THAT THE CUSTOMER INSTALL A CANNULA ON ARM 3 AND POWER CYCLE THE SYSTEM. THE CUSTOMER PERFORMED THIS, BUT THE ERROR WAS STILL PRESENT. THE CUSTOMER STATED THAT THEY WERE GOING TO SWAP ROBOTS BUT WERE GOING TO SPEAK WITH THE SURGEON FIRST. THE CUSTOMER WAS HAVING TROUBLE MOVING THE ORIGINAL PATIENT SIDE CART (PSC) OUT OF THE WAY. THE TSE WALKED THE CUSTOMER THROUGH THE STEPS TO RESOLVE THE ISSUE AND THE CUSTOMER WAS ABLE TO MOVE THE PSC OUT OF THE WAY TO BRING IN THE NEW PSC. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931592 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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