BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16237134 · Received January 24, 2023

    Report

    Report Number
    2955842-2023-10279
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 4, 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
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. IN THE LOGS, 25745 BUTTON ERRORS WERE SEEN POINTING TO THE CANNULA. ON THE SYSTEM, IT WAS CONFIRMED THAT THE CANNULA PORT CLUTCH BUTTON WAS NOT FUNCTIONING AND TRIGGERED THE 25745 ERROR. THE UNIT PASSED ALL OTHER TESTS THAT WERE PERFORMED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SIDE MANIPULATOR (USM) ARM 2 PORT CLUTCH, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE ISSUE AND REPLACED UNIVERSAL SURGEON MANIPULATOR (USM) DUE TO THE PORT CLUTCH NOT WORKING. THE REPLACED USM ARM WAS RECEIVED BY ISI FOR FAILURE ANALYSIS; HOWEVER, INVESTIGATION IS CURRENTLY ONGOING. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INVESTIGATION IS CURRENTLY IN PROGRESS, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE FIELD SERVICE ENGINEER (FSE) REPLICATED THE REPORTED PROBLEM AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM TO CORRECT THE REPORTED PROBLEM. 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 CONVERSION/ABORTION.

    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 UROLOGY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) AND SURGEON CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT UNIVERSAL SIDE MANIPULATOR (USM) ARM 2 PORT CLUTCH WAS NOT WORKING WHEN SURGEON STARTED TO PERFORM THE SURGERY. TSE DID NOT FIND ANY ERRORS POINTING TO THIS PROBLEM. TROUBLESHOOTING WAS PERFORMED THROUGH A HARD POWER CYCLE INCLUDING EMERGENCY POWER OFF (EPO) WHICH DID NOT SOLVE THE ISSUE. SURGEON WAS ABLE TO USE THE GRAB & MOVE FEATURE AND STARTED SURGERY WITHOUT FURTHER PROBLEMS. THE FSE STATED THAT OTHER BUTTONS ON THE USM ARM WORKED, AND THEY WERE NOT HEARING THE BEEP SOUND AFTER PUSHING THE PORT CLUTCH. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732580 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

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