BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18038458 · Received October 31, 2023

    Report

    Report Number
    2955842-2023-19805
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 4, 2023
    Report Date
    October 4, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND CUSTOMER INFORMED THAT THE ISSUE RESOLVED AFTER THE POWER PLUG WAS PULLED OUT OF THE WALL POWER OUTLET RECEPTACLE. NO SYSTEM ISSUE WAS CONFIRMED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A NON-RECOVERABLE ERROR FAULT AFTER INADVERTENTLY HITTING THE POWER PLUG CONNECTION TO WALL POWER OUTLET. THE SYSTEM THEN ALERTED WITH HIGH PITCHED ALARM THAT WAS UNABLE TO BE CLEARED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE INDICATED THAT THEY ARE UNABLE TO RECOGNIZE A HIGH-PITCHED ALARM AS A SOUND THAT A DAVINCI SYSTEM WILL TYPICALLY PRODUCE. THE CUSTOMER PROVIDED THE SYSTEM INFORMATION AND STATED THAT THE SURGEON ALREADY ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY DUE TO PATIENT ANATOMY AND FURTHER INDICATED THAT IT WAS NOT SYSTEM RELATED. AFTER THIS, THE CUSTOMER ENDED THE CALL. TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED A RELATED ERROR FAULT CONFIRMING THE EVENT. THE ERROR FAULT WAS CLEARABLE; HOWEVER, NO TROUBLESHOOTING WITH THE TSE WAS PERFORMED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IT WAS STATED THAT THE OPERATING ROOM POWER OUTLET WAS FOUND TO BE OVERUSED. AT THE TIME OF THE EVENT, THE CUSTOMER NOTICED THAT THE SYSTEM LIGHTS WERE RED WHEN THE SYSTEM WAS DISCONNECTED. CUSTOMER CONFIRMED THAT THE NOISE WAS ACTUALLY COMING FROM THE OMNICELL AND NOT THE SYSTEM. IT WAS AGAIN CONFIRMED THAT THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE PATIENT'S ANATOMY. THERE WAS NO SYSTEM ISSUE TO CONSIDER, THE SYSTEM HAD NOTHING TO DO WITH THE DECISION TO CONVERT TO OPEN SURGERY. THERE WAS NO KNOWN PATIENT HEALTH COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123996 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-42 N/A 00886874110720

    Patients

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