BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18794038 · Received February 27, 2024

    Report

    Report Number
    2955842-2024-11841
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 1, 2024
    Report Date
    April 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED BOTH THE PROXIMAL OUTER SET UP JOINT (PSUJ) AND THE DISTAL OUTER SUJ TO PERFORM FAILURE ANALYSIS. THE PROXIMAL SUJ WAS EVALUATED. THE 319 ERROR WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD VIA SYSTEM LOGS REVIEW BUT COULD NOT BE REPLICATED DURING THE FAILURE ANALYSIS INVESTIGATION. THE DISTAL SUJ WAS TESTED ON THE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND PASSED ALL TESTS. ERROR 319 WAS NOT REPLICATED, BUT IT WAS CONFIRMED IN SYSTEMS LOGS.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM), PROXIMAL SET UP JOINT (SUJ), AND DISTAL SUJ. THE FSE ALSO REPLACED THE BACKPLANE FIBER OPTIC CABLE (FOC), PATIENT SIDE CART (PSC) TAP FOC, AND PSC WRIST FOC. MULTIPLE PARTS WERE REPLACED ON THE SYSTEM, BUT THERE WAS NO RESOLUTION TO ERROR 319 UNTIL THE BACKPLANE FIBER OPTIC CABLE WAS REPLACED. THE FIBER OPTIC CABLE PSC TAP FIBER OPTIC CABLE AND PSC WRIST FIBER OPTIC CABLE WERE SCRAP ITEMS AND WILL NOT BE RETURNED BACK TO ISI. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE USM, PROXIMAL SUJ AND DISTAL SUJ. FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED BOTH THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO PERFORM FAILURE ANALYSIS. THE UNIT WAS RETURNED AND CONFIRMED VIA LOGS BUT NOT REPLICATED. IT WAS DETERMINED DURING FURTHER INSPECTION THAT THE WRONG PART WAS SENT BACK.

    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 NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY HAD POWERED ON THE SYSTEM AND WERE GETTING ERROR 319. THE LOGS SHOWED THE ERROR POINTED TO UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE TSE REQUESTED THE CUSTOMER EXERCISE ARM 4 AND EMERGENCY POWER OFF (EPO) THE SYSTEM. AFTER SEVERAL ATTEMPTS, THE ERROR RETURNED EACH TIME. THE TSE INSTRUCTED THE CUSTOMER ON HOW TO DISABLE THE ARM AND TO CONTINUE PROCEDURE AS A 3-ARM PROCEDURE. THE CUSTOMER WAS OKAY TO PERFORM THE PROCEDURE WITH 3-ARMS BUT DID NOT WANT TO MANUALLY DEPLOY FOR DOCKING. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE TSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE ISSUE WAS REPORTED PRIOR TO STARTING POST ANESTHESIA WITH PORTS PLACED AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895059 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A

    Patients

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