BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17167894 · Received June 20, 2023

    Report

    Report Number
    2955842-2023-16463
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 30, 2023
    Report Date
    May 30, 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
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. FAILURE ANALYSIS (FA) WAS ABLE TO CONFIRM AND REPRODUCE THE REPORTED COMPLAINT. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND TO PRODUCE ERROR 319 WHEN INSTALLED ONTO AN IN-HOUSE SYSTEM. THE USM ALSO FAILED FIBER TESTING, INDICATING CLOCK SPRING FIBER ISSUE. THE COMPLAINT REGARDING ERROR 319 WAS CONFIRMED BY FA, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE RECOVERABLE FAULT ISSUE WITH ARM 3, AN INVESTIGATION IS IN PROGRESS 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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER AND THAT THE USM UNIT WAS RECEIVED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S) HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION IS BEING GATHERED AND THE FAILURE ANALYSIS IS STILL IN PROGRESS AND AS SUCH, THE PROBABLE ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE FAILURE ANALYSIS HAS BEEN COMPLETED.

    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 SURGICAL PROCEDURE, REPEATED RECOVERABLE FAULTS 319 OCCURRED ON ARM 3. THE SITE MOVED FORWARD WITH THE CASE AS A 3-ARM SYSTEM. ONSITE WAS NOT WORKING AT THE TIME OF THE CALL. THERE WERE NO REPORTS OF PATIENT INJURY. THE SITE CALLED BACK AFTER THE PROCEDURE TO TROUBLESHOOT THE ERROR. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) ASKED THE STAFF TO CYCLE THE SYSTEM POWER, PERFORM AN EMERGENCY POWER OFF (EPO), AND PLACE THE CIRCUIT BREAKER DOWN ON THE PATIENT SIDE CART (PSC). THE REPORTED ERROR RETURNED ON POWER UP. THE TSE ADVISED THE SITE THAT ARM 3 WOULD NEED TO BE SERVICED, AND ONLY THE OTHER 3 ARMS WOULD BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692411 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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