BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 18450479 · Received January 5, 2024

    Report

    Report Number
    2955842-2023-21951
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 14, 2023
    Report Date
    December 14, 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
    CH
    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 EVENT. THE ISI FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE ENDOSCOPE, BUT THE ISSUE WAS NOT RESOLVED. THE ISI FSE SWAPPED THE LEFT AND RIGHT CABLE BEHIND THE DUAL CAMERA CONTROL UNIT (DOCO), AND THE ISSUE OCCURRED ON THE LEFT SIDE INSTEAD OF THE RIGHT SIDE AT THIS TIME. THE ISI FSE REPLACED THE DOCO TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DUAL CAMERA CONTROL UNIT (DOCO) TO PERFORM ANALYSIS. THE DOCO WAS INSTALLED ON AN IN-HOUSE SYSTEM. THE UNIT PASSED ALL THE TESTS WITHOUT ANY ISSUE. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THE HIGH-RESOLUTION STEREO VIEWER (HRSV) AND VISION SIDE CART (VSC) RIGHT IMAGE WAS BLURRY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) RECEIVED PHONE ASSISTANCE FROM THE ISI TECHNICAL SUPPORT ENGINEER (TSE). PRIOR TO THE PHONE CALL, THE SITE USED A BACKUP ENDOSCOPE AND POWER CYCLED THE SYSTEM, BUT THE ISSUE WAS NOT RESOLVED. THE ISI CSR CONFIRMED THAT THE CAMERA HEAD WAS CLEAN. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING THE SYSTEM. NO ERROR WAS REPORTED EXCEPT FOR THE BLURRY RIGHT EYE ISSUE. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761168 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-21 00886874110683

    Patients

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