BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 19396844 · Received May 24, 2024

    Report

    Report Number
    2955842-2024-14756
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 27, 2024
    Report Date
    April 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRAOPERATIVE COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THE REPORTED EVENT WAS NOT REPRODUCED NOR CONFIRMED. THE FSE REVIEWED THE SYSTEM LOGS, AND NO ERRORS WERE FOUND. THEY THEN CONDUCTED ELECTRICAL SAFETY TESTS, AND THE TEST VALUES WERE WITHIN THE NORMAL RANGE. THE SYSTEM PASSED VERIFICATION. THE FSE WILL FOLLOW-UP WITH THE SITE IF A SIMILAR SITUATION REOCCURS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO PRODUCT HAS BEEN RETURNED TO ISI FOR EVALUATION. .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION, AND THE FOLLOWING WAS PROVIDED: IT WAS UNKNOWN IF THE STATIC SHOCK WAS FROM STATIC ELECTRICITY. THERE WAS NO TISSUE DAMAGE TO THE SURGEON AS A RESULT OF THIS EVENT. THE SURGEON DID NOT REQUIRE MEDICAL LEAVE AS A RESULT OF THIS EVENT. THE PATIENT DID NOT EXPERIENCE TISSUE DAMAGE AS A RESULT OF THIS EVENT. IT WAS UNKNOWN WHICH TYPE OF ENERGY WAS ACTIVATED WHEN THE EVENT OCCURRED. IT WAS UNKNOWN WHICH ENERGY INSTRUMENT WERE IN USE AT THE TIME OF THE EVENT. THE ENERGY INSTRUMENT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE ENERGY INSTRUMENTS WERE CONNECTED PROPERLY. THE ELECTROSURGICAL UNIT IN USE WAS A COVIDIEN GENERATOR, AND THE SETTING USED WERE UNKNOWN. IT WAS UNKNOWN IF ANY PORT INCISIONS WERE INCREASED OR ADDITIONAL PORTS PLACED WHEN THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THE ACTIONS TAKEN TO RESOLVE THE ISSUE WERE UNKNOWN. THE REASON THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WAS UNKNOWN. THE GENERATOR WAS NOT REPLACED DURING THE PROCEDURE IN AN ATTEMPT TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE SURGEON FELT LEAKAGE ON THE RIGHT MASTER TOOL MANIPULATOR (MTMR) WHEN THE SURGEON ACTIVATED ENERGY. THIS ISSUE WAS ESPECIALLY APPARENT WHEN TRIGGERING MONOPOLAR ENERGY, AND IT WAS NOT FELT WITH THE LEFT MTM. THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TEAM, WHO GUIDED THE SITE TO REPLACE THE GENERATOR WITH THE BACK-UP INTEGRATED ELECTROSURGICAL UNIT (IESU). PER THE CUSTOMER, THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY TO CONTINUE THE PROCEDURE. THE TSE REVIEWED THE SYSTEM LOGS, AND NO ERRORS WERE REPORTED BY THE SYSTEM AT THE TIME OF THE EVENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    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
    643782 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-12 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other DA VINCI INSTRUMENTS AND ACCESSORIES