BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 15612725 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14621
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    September 15, 2022
    Report Date
    September 15, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 FSE CHECKED THE SYSTEM ERROR LOGS AND DID NOT FIND ANY ERROR REGARDING THIS ISSUE. THE FSE SWAPPED THE BLUE FIBER OPTIC CABLE OF SURGEON SIDE CONSOLE (SSC1) AND SSC2. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A LOG REVIEW CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6)2022 ON SYSTEM SH1762. THIS COMPLAINT IS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT MOVEMENT INTERMITTENTLY STUCK. UNCONTROLLED/ UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE INSTRUMENT MOVEMENT INTERMITTENTLY STUCK AND THE SYSTEM STARTED WORKING WITHOUT ANY INTERVENTION. THE SURGEON WAS EXPERIENCING THE ISSUE TO BOTH LEFT AND RIGHT CONTROL. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO ADJUST THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO MAKE SURE ALL HEAD SENSORS WERE BLOCKED AND REBOOT THE SYSTEM. THE SYSTEM WAS NOT CONNECTED TO THE NETWORK DURING THE EVENT, SO LIVE LOGS WERE NOT AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6)2022 : THE REPORTED ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE AND THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE. THE MOVEMENTS OF THE SURGEON SCALE WERE APPROPRIATE TO THE INSTRUMENT AND THE INSTRUMENT WAS MOVING IN THE INTENDED DIRECTION. THE INSTRUMENT MOVEMENT TIMING WAS ALSO APPROPRIATE. THE CUSTOMER DID NOT EXPERIENCE ANY SHAKINESS AND/OR FRICTION AND THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THE REPORTED ISSUE WAS INTERMITTENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744019 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-10 N/A 00886874110690

    Patients

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