BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16840037 · Received April 28, 2023

    Report

    Report Number
    2955842-2023-12276
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM ANALYSIS. THE HIGH-RESOLUTION STEREO VIEWERS (HRSV) INSTRUMENT WAS ANALYZED AND REPORTED FAILURE WAS REPLICATED. THE MONITOR WAS INSTALLED AND TESTED IN THE PRINTED CIRCUIT ASSEMBLY (PCA) SI SYSTEM, THE SYSTEM STARTED UP AND FAILED WITHOUT VIDEO ON THE DISPLAY. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE. THE COMPLAINT REGARDING HRSV LEST EYE ISSUE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING HIGH-RESOLUTION STEREO VIEWER (HRSV) LEFT EYE ISSUE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) REPRODUCED AND REPLACED THE HRSV TO RESOLVE THE REPORTED PROBLEM. SYSTEM TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE HIGH-RESOLUTION STEREO VIEWER (HRSV) LEFT EYE WAS BLACK. THE SURGEON ELECTED TO CONTINUE WITH THE PROCEDURE WITH THE SYSTEM AS IS. 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/ABORTED AND 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 SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT DURING FOLLOWING MODE, SURGEON OBSERVED THAT THE LEFT EYE OF THE HIGH-RESOLUTION STEREO VIEWERS (HRSV) IS BLACK. TSE ADVISED THE NURSE TO TOGGLE LEFT/RIGHT (L/R) VIDEO ON VISION SIDE CART (VSC) AND BOTH VIDEO DISPLAYS WAS CORRECT. SYSTEM WAS ALSO RESTARTED BUT ISSUE ON THE HRSV PERSISTED. SURGEON DECIDED TO PROCEED WITH SURGERY DESPITE THE LEFT HRSV ISSUE AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523162 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-11 N/A 00886874110683

    Patients

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