BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21690059 · Received March 25, 2025

    Report

    Report Number
    2955842-2025-11398
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    February 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE AND RISK CANNOT BE ESTABLISHED BASED ON THE INFORMATION PROVIDED AND FIELD SERVICE ENGINEER'S (FSE) FIELD EVALUATION. THE FSE'S SERVICE VISIT DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    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. FSE WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT. GUIDED TOOL CHANGE SUCCESSFUL FOR ALL ARMS MULTIPLE TIMES. THE FSE ADVISED ACCOUNT TO OBSERVE SERIAL NUMBER OF INSTRUMENT IF ISSUE ARISES AGAIN. SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE. ACCORDING TO THE CUSTOMER, WHEN THE INSTRUMENT WAS CHANGED OUT, THE CLUTCH BUTTONS WERE NOT PRESSED. THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM DID NOT SAVE THE LAST POSITION. WHEN THE CUSTOMER PRESSED THE CANNULA CLUTCH BUTTON, THE USM ARM WIGGLED OUT WHILE THE INSTRUMENT WAS IN THE PATIENT'S BELLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI OBTAINED THE FOLLOWING INFORMATION FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR): THE SURGEON WAS IN THE CONSOLE WHEN THE ISSUE HAPPENED, AND IT HAPPENED ON SEVERAL OCCASIONS. HE SPOKE TO THE HOSPITAL EMPLOYEES, BUT THEY WERE NOT ABLE TO GIVE AN EXACT TIME IT HAPPENED OR THE EXACT SEQUENCE OF EVENTS. THE ISSUE WAS RECTIFIED COMPLETELY WITH THE ADDITIONAL A NEW ARM INSTALLATION. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358972 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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