BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 15443277 · Received September 18, 2022

    Report

    Report Number
    2955842-2022-14056
    Event Type
    Malfunction
    Date Received
    September 18, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 18, 2022
    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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE CUSTOMER REPORTED THAT THE ILLUMINATOR LIGHT BECAME BLUE, SO THEY USED AN EXTERNAL ILLUMINATOR TO COMPLETE THE PROCEDURE. THE FSE REPLACED THE ILLUMINATOR AND RESOLVED THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED THE CUSTOMER REPORTED COMPLAINT OF ¿BLUE LIGHT VISIBLE". WHEN REVIEWING THE REMOTEFE LOGS DURING TESTING, THERE WERE SEVERAL 48240 ERRORS WHICH POINTED TO AN ILLUMINATOR COMMUNICATIONS ERROR. THE ILLUMINATOR WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ANY ERRORS, BUT THE WHITE BALANCE FAILED. A REVIEW OF THE PROCEDURE LOGS SHOWED THE SITE PERFORMED THE BENIGN HYSTERECTOMY SURGICAL PROCEDURE ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THIS EVENT IS BEING REPORTED BECAUSE THE ILLUMINATOR WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH ANOTHER LIGHT SOURCE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED THE LIGHT COLOR TURNED BLUE. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER MOVED THE LIGHT GUIDE CABLE TO AN EXTERNAL LIGHT SOURCE. THE PROCEDURE WAS CONTINUING WITH THE EXTERNAL LIGHT SOURCE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THE ILLUMINATOR INITIALLY POWERED ON WITHOUT ERRORS OR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222249 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

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