BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18165365 · Received November 17, 2023

    Report

    Report Number
    2955842-2023-20237
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 31, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE ADVERSE EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND TESTED THE DEVICE. THE FSE WAS UNABLE TO REPRODUCE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SYSTEM LOGS FOR THE SYSTEM SK2307 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE SYSTEM LOGS FROM THIS EVENT WAS REVIEWED AND CAN CONFIRM THAT THE EVENT WAS DETECTED BY THE SYSTEM. THE FOLLOWING ALARMS WERE RECORDED: ERROR 25913 M-C1: THE ENERGY PEDAL OR THE BOVIE PEN FINGER SWITCH REQUESTED ACTIVATION OVER THE MAXIMUM ALLOWABLE AMOUNT OF TIME. ERROR 25913 M-10: THE PREVIOUS ERROR (25913 M-C1) AUTO-STOPPED ENERGY ACTIVATION TO THE BOVIE PEN BUT THE SURGEON SIDE CONSOLE (SSC) PEDAL OR BOVIE FINGER SWITCH CONTINUED TO REQUEST POWER. ERROR 25913 M-32: MULTIPLE ACTIVATION REQUESTS (LIKELY OCCURRED WHEN OR STAFF WAS TROUBLESHOOTING). THE SYSTEM LOGS INDICATE THAT AN ATTACHED DEVICE WAS REQUESTING POWER FOR AN INAPPROPRIATE AMOUNT OF TIME, CONSISTENT WITH THE REPORTED EVENT. THE LOGS DO NOT INDICATE WHETHER OR NOT THIS ENERGY REQUEST CAME FROM THE SURGEON SIDE CONSOLE (SSC) PEDAL OR THE BOVIE PEN. THE PROBABLE ROOT CAUSE OF THE ALLEGED FIRING PROBLEM CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION. FSE WAS UNABLE TO REPRODUCE THE REPORTED ERROR. THE FSE'S SERVICE VISIT DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED CYSTO-PROSTATECTOMY, BILATERAL PELVIC LYMPH NODE DISSECTION WITH ILEAL CONDUIT URINARY DIVERSION PROCEDURE. THE BOVIE PEN WAS CONNECTED TO THE ERBE GENERATOR AND WAS ON STANDBY. DURING THE PROCEDURE, THE BOVIE PEN ALLEGEDLY ACTIVATED ON ITS OWN, IT WAS ON FOR AROUND 10-15 SECONDS AND WITHOUT PRESSING THE PEDAL OF THE ROBOT NOR CAUTERY. THE PHYSICIAN ENSURED THAT DURING THE EVENT, THE FOOT PEDAL WAS NOT ACTIVATED. THERE WAS NO ARCING AND NO INSTRUMENT COLLISION. THE BOVIE PEN SELF-ACTIVATION CAUSED PERFORATION OF THE PROXIMAL SMALL BOWEL. THE PERFORATION WAS REPAIRED BY SMALL BOWEL RESECTION AND ANASTOMOSIS. THE PROCEDURE WAS NOT CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674236 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-32 N/A 00886874110898

    Patients

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