BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14325860 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11473
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    September 1, 2020
    Report Date
    September 2, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN OLD DAMAGED NON-FUNCTIONAL ILLUMINATOR (PART # 951183-04), WHICH REPORTEDLY HAD BEEN IN USE FOR NEARLY 10 YEARS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM ERROR LOGS AND FOUND ILLUMINATOR ERRORS 48240 AND 48239. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE THEN REPLACED THE OLD DAMAGED/BROKEN UNIT WITH A NEW ILLUMINATOR AS WELL AS INSTALLING A NEW LAMP TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. EVALUATION OF THE RETURNED ILLUMINATOR UNIT FOUND SEVERAL COSMETIC ISSUES (BURN MARKS ON MODULE TRAY / DAMAGED FRONT BEZEL) AND MECHANICAL ISSUES (BROKEN EXHAUST FAN), AND THIS CAUSED THE REAR RIGHT-SIDE FAN TO BECOME INOPERABLE. FURTHERMORE, IN-HOUSE TESTING FOUND THE ILLUMINATOR WAS OVERHEATING TO A SERIOUS DEGREE AFTER 15 POWER CYCLES. NO IMAGE OR VIDEO CLIP OF THE REPORTED EVENT WAS PROVIDED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC APPROACH DUE TO THE REPORTED ILLUMINATOR ISSUE. THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES FOLLOWING THE CONVERSION AND NO THERE WAS NO PATIENT INJURY. AT THIS TIME, AVAILABLE INFORMATION INDICATED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A NON-FUNCTIONAL ILLUMINATOR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGICAL STAFF HEARD A POP SOUND FROM THE VISION CART AND THE ROOM SMELLED LIKE SMOKE. THE CUSTOMER ALSO REPORTED THAT THE ¿SYSTEM IS CONTINUING TO WORK NORMAL AND THAT THEY ARE CONTINUING WITH THE CASE." ON 04-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE ROBOTICS COORDINATOR, WHO INDICATED THAT AFTER CONTACTING ISI TECHNICAL SUPPORT, THE SITE DID NOT CONTACT THE TECHNICAL SUPPORT AGAIN BEFORE CONVERTING THE PROCEDURE TO LAPAROSCOPIC DUE TO THE REPORTED ISSUE. THE ROBOTICS COORDINATOR ALSO CONFIRMED THAT THE LAPAROSCOPIC SURGERY WAS COMPLETED AND THERE WAS NO REPORTED PATIENT INJURY NOR HAS THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351711 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-03 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES