BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16569787 · Received March 18, 2023

    Report

    Report Number
    2955842-2023-11374
    Event Type
    Malfunction
    Date Received
    March 18, 2023
    Date of Event
    February 24, 2023
    Report Date
    February 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FLICKERING WITH REPEATED ERROR 48245, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER REPLACED THE LAMP MODULE. INTUITIVE SURGICAL, INC. (ISI) DEVICE RECEIVED THE LAMP MODULE FOR A FAILURE ANALYSIS (FA). FA COULD NOT REPRODUCE THE FLICKERING IMAGE DURING TESTING. THE UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT HAS CONSTANT LIGHT OUTPUT THROUGHOUT THE TESTING PERIOD. NO PHYSICAL DAMAGE NOTED ON THE EXTERIOR OF THE LAMP MODULE. THE UNIT WAS NOTED WITH ERROR 48247 UPON INSTALLATION ONTO THE TEST SYSTEM. THE ERROR OCCURRED DUE TO A COMMUNICATION ISSUE BETWEEN ILLUMINATOR AND THE LAMP MODULE. THE COMMUNICATION ISSUE WAS CAUSED BY INVALID/CORRUPT ID OR ENCRYPTION DATA. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE LAMP MODULE WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP LAMP MODULE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START, POST PORTS PLACEMENT OF A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD RECOVERABLE ERROR OCCURRED. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM ERROR LOGS AND CONFIRMED ERROR 48245, WHICH WAS DUE TO THE LAMP MODULE BEING TURNED ON WHILE ITS INSIDE WAS HOT. THE CUSTOMER STATED THAT HE TRIED MULTIPLE TIMES TO LIGHT THE LAMP MODULE, BUT THE ERROR PERSISTED. THE CUSTOMER REPLACED THE LAMP MODULE. HOWEVER, A NEW ERROR 48247 OCCURRED ON THE NEW LAMP MODULE. THE TSE HAD THE CUSTOMER PERFORMED HARD POWER CYCLE THE VISION SIDE CART (VSC), WHICH RESOLVED THIS ERROR WITH THE NEW LAMP MODULE. THE TSE ADVISED THE CUSTOMER TO CHECK THE ORIGINAL LAMP MODULE AFTER THE PROCEDURE. IN THE THIRD PHONE CALL, THE CUSTOMER REPORTED THAT ERROR 48245 REOCCURRED WHEN HE CHECKED THE ORIGINAL LAMP MODULE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PORTS WERE PLACED. AFTER THE CUSTOMER REPLACED THE LAMP MODULE, ERROR 48247 OCCURRED ON THE NEW LAMP MODULE. THIS NEW ERROR COULD BE RESOLVED BY PERFORMING HARD POWER CYCLE THE VISION SIDE CART (VSC). THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998547 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

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