BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19734366 · Received July 12, 2024

    Report

    Report Number
    2955842-2024-16770
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE REDUNDANT POWER TRAY ASSEMBLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY 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 INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    THE REDUNDANT POWER TRAY HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THIS UNIT WAS INSTALLED INTO THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM AND WHEN STARTED UP, ERROR 86 APPEARED. THE INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) WAS REPLACED, AND THE SYSTEM WAS LEFT TO BURN IN OVERNIGHT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE XI SYSTEM PRESENTED ERROR 86. THE SYSTEM WAS RESTARTED WITHOUT SUCCESS. REMOTE SUPPORT WAS PROVIDED BY STRATTNER TECHNICAL ASSISTANCE, WHICH PERFORMED SOME ACTIONS, BUT IT WAS NOT POSSIBLE TO SOLVE THE PROBLEM REMOTELY. SURGERY CONVERTED TO VIDEO LAPAROSCOPY. PROCEDURE COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. ISI TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING PRIOR TO CONVERTING THE PROCEDURE, PARTS WERE ORDERED AND COMPLETED THE NEXT DAY. PORT INCISIONS WERE NOT INCREASED OR ADDED. THE PATIENT TOLERATED THE CONVERSION. THERE WAS NO INJURY TO THE PATIENT. THE HOSPITAL DOES NOT PROVIDE PATIENT INFORMATION.

    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
    894344 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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