BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 13257084 · Received January 14, 2022

    Report

    Report Number
    2955842-2022-10063
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 16, 2021
    Report Date
    December 16, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) AS A PRECAUTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE MCS TIP COVER ACCESSORY, NOR THE IESU HAVE BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THESE PRODUCTS CANNOT BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND NO OTHER COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WERE PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT ARCED DURING THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 0

    D10, D14 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, TIP COVER ACCESSORY AND INTEGRATED ELECTRO SURGICAL UNIT (IESU) UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) COULD NOT REPRODUCE THE REPORTED COMPLAINT ON THE MCS INSTRUMENT. VISUAL INSPECTION WAS PERFORMED, AND NO THERMAL DAMAGE WAS OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS/TIPS (FOR SCISSORS) OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS WERE PERFORMED AND PASSED. NO ARCING WAS OBSERVED. THERE WAS NO PROBLEM DETECTED. FA COULD NOT REPRODUCE THE REPORTED COMPLAINT ON THE MCS TIP COVER ACCESSORY. VISUAL INSPECTION WAS PERFORMED, AND NO DAMAGE WAS OBSERVED. NO THERMAL DAMAGE WAS OBSERVED. THE UNIT WAS INSTALLED ON AN IN-HOUSE MCS INSTRUMENT AND DRIVEN ON AN IN-HOUSE SYSTEM. ENERGY DELIVERY WAS PERFORMED, AND NO ARCING WAS OBSERVED. FA COULD NOT REPRODUCE THE REPORTED COMPLAINT ON THE IESU. THE UNIT ENERGIZED/CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. AS A SAFETY PRECAUTION, THE UNIT WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, AND H3. ANALYSIS RESULTS CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10.

    Additional Manufacturer Narrative · 0

    THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) COULD NOT REPLICATE REPORTED ISSUE ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) DUE TO NOT BEING ABLE TO REPLICATE THE CUSTOMER SETUP. ALL OUTPUT VALUES WERE WITHIN SPECIFICATION. AN ADDITIONAL FINDING UNRELATED TO THE REPORTED COMPLAINT WAS FOUND: BIPOLAR CUT WAS AT THE TOP END OF THE TOLERANCE AT 120 WATTS, REQUIRING CALIBRATION. THE UNIT¿S TOP COVER AND FRONT FRAME WERE REPLACED DUE TO SCRATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCED AFTER 30 MINUTES OF USE. THE SITE CONTINUED TO COMPLETE THE PROCEDURE AS PLANNED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL (IS) MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE COMPLAINT; HOWEVER, ATTEMPTS WERE NOT SUCCESSFUL.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806558 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES