BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 20666004 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21749
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    Additional Manufacturer Narrative · 0

    THE PATIENT SIDE MANIPULATOR (PSM) WAS TESTED ON THE IN-HOUSE SYSTEM. THE INSERTION AXIS WAS VERY DIFFICULT TO MOVE. THE RELEASE LEVER WILL BE REPLACED AS A FIX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INSERTING AXIS OF THE INSTRUMENT IS VERY HARD TO MOVE. BEFORE CALLING, THEY ALREADY MOVED TO AN OPEN PROCEDURE AND NO MORE TROUBLE SHOOTING WAS POSSIBLE. THE TSE CHECKED THE LOGS, BUT NO LOGS WERE UPLOADED FOR THIS DAY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: ACCORDING TO THE SURGEON THE ISSUE WAS DUE TO MECHANICAL PROBLEM AND THE SITE DID A TROUBLESHOOTING. THEY LOOKED AT THE TROCAR, LOOKED AT THE PLASTIC AROUND THE ARM. THE ARM WAS NOT MOVING CORRECTLY WHICH MADE THEIR SURGICAL ACTIONS DANGEROUS. THE SYSTEM WAS INSPECTED PRIOR TO USE. THE SITE ALWAYS DOES A TIME-OUT BEFORE SURGERY. THE FUNCTION COULD ONLY BE TESTED WHEN THE SURGERY WAS ALREADY STARTED, AND THE TROCAR WERE ALREADY INTRODUCED INTO THE PATIENT. THERE WERE NOT ANY ISSUES NOTED DURING SET UP OF THE SYSTEM. THE ISSUES WERE THERE FROM THE START, HOWEVER, THE SITE MOVED ON BECAUSE THEY THOUGHT IT HAD TO DO WITH POSITION OF THE ARMS. WORKING FROM THE PULMONARY LIGAMENT UP TOWARD DE HILUM. HOWEVER, WHEN DISSECTING ON THE PULMONARY ARTERY THE SITE STILL HAD THE SAME PROBLEMS, AND DECIDED THE OPERATION WAS NOT SAFE. VIDEO RECORDING WAS NOT ACTIVE AT THAT TIME, WHICH WAS SOMETIMES A PROBLEM DURING SURGERY, THE VIDEO RECORDING SOMETIMES SHUTS OFF. THE PATIENT KNEW IF THERE WAS A TECHNICAL PROBLEM THAT AN OPEN PROCEDURE WAS POSSIBLE. THE PATIENT WAS OF COURSE NOT HAPPY TO THE CHANGE. THE ISSUE WITH THE VIDEO RECORDING WAS NOT A PROBLEM IN THE DA VINCI SYSTEM. IN ISALA THEY HAVE A RECORDING SYSTEM "BARCO NEXXIS SYSTEM", SOMETIMES THIS RECORDING SYSTEM HAS PROBLEMS WITH RECORDING.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135111 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-08 N/A

    Patients

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