BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 17046173 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15551
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    June 30, 2021
    Report Date
    June 30, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110775
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    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 REPORTED COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED EVENT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE POWER SUPPLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT REPRODUCE THE REPORTED EVENT, BUT THE EVENT WAS CONFIRMED VIA LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) TURNED TO BATTERY MODE. THE FIELD SERVICE ENGINEER (FSE) WAS AT THE SITE FOR A CASE OBSERVATION AND HAD PERFORMED A HARD POWER CYCLE TO MAKE THE SYSTEM READY FOR USE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND REVIEWED THE ERROR AND FOUND 817. THE TSE STATED THE AUXILLARY POWER BOARD (APB) OR MEDICAL GRADE POWER SUPPLY (MGPS) MAY HAVE MALFUNCTIONED DURING THE TIME OF EVENT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE. THE PSC SWITCHED TO BATTERY MODE AND UNABLE TO BRING TO NORMAL MODE. NO TROUBLESHOOTING WAS PERFORMED WITH DVSTAT. THERE WERE NO ISSUES NOTED DURING SET UP OF THE SYSTEM AND THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ISSUES WITH THE PORT PLACEMENT(S) AND THE SURGICAL STAFF DID NOT OBSERVE THAT THERE WERE ANY OUTSIDE INFLUENCES THAT WERE IMPEDING MOVEMENT OF THE SYSTEM / PATIENT SIDE MANIPULATORS (PSM). TROUBLESHOOTING STEPS WERE PERFORMED WITH THE FSE BUT TECHNICAL SUPPORT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31647 DAVINCI SI PATIENT SIDE CART, RECERTIFIED NAY INTUITIVE SURGICAL, INC 380686-04 N/A 00886874110775

    Patients

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