BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16196588 · Received January 18, 2023

    Report

    Report Number
    2955842-2023-10141
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    December 19, 2022
    Report Date
    December 19, 2022
    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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MEDICAL GRADE POWER SUPPLY (MGPS) WAS ANALYZED AND FOUND THE FANS WERE DIRTY DURING VISUAL INSPECTION. FAILURE ANALYSIS CONFIRMED THE REPORTED PROBLEM. THE POWER SUPPLY WAS INSTALLED INTO A TEST SYSTEM AND STARTED-UP NORMALLY WITH NO ERROR. THE CURRENT DRAW IS HIGH DURING TESTING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MEDICAL GRADE POWER SUPPLY (MGPS) WAS ANALYZED AND FOUND THE FANS WERE DIRTY DURING VISUAL INSPECTION. FAILURE ANALYSIS CONFIRMED THE REPORTED PROBLEM. THE POWER SUPPLY WAS INSTALLED INTO A TEST SYSTEM AND LOST POWER WITH ERROR 418 MEANING, "OPERATING BELOW MINIMUM OPERATING LOAD".

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 31220 WITH A MESSAGE INDICATING THE SYSTEM IS RUNNING ON BATTERY, AN INVESTIGATION WAS 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 CONFIRMED THE REPORTED PROBLEM AND REPLACED THE MEDICAL GRADE POWER SUPPLY 1 (MGPS1) AND MGPS2 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A RECOVERABLE ERROR 31220 OCCURRED WITH A MESSAGE INDICATING THE SYSTEM IS RUNNING ON BATTERY. THE CUSTOMER TRIED TO CONNECT THE POWER CABLE TO DIFFERENT SOURCES BUT WITHOUT SUCCESS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED TO HARD POWER CYCLE BY PRESSING THE EMERGENCY POWER OFF; HOWEVER, THE SYSTEM DISPLAYED ERRORS 1152 AND 417. THE CUSTOMER REPORTED A PROCEDURE DELAY OF GREATER THAN 30 MINUTES. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPY WITH NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068731 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES