BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21389865 · Received February 14, 2025

    Report

    Report Number
    2955842-2025-01544
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS COMPLETED. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: AN ERROR INDICATING A SURGEON'S HAND MAY NOT HAVE BEEN TOUCHING THE LEFT MASTER TOOL MANIPULATOR (MTM) WHILE IN FOLLOWING MODE ON SURGEON SIDE CONSOLE (SSC) #2.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD NOT REPLICATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED AN ETHERNET CABLE PASS THROUGH AND CLEARED LINT AND DEBRIS FROM AROUND THE SURGEON SIDE CONSOLE (SSC) HEAD SENSORS. THE FSE TEST RAN THE SYSTEM AND FOUND NO TROUBLE. THE EVENT INVESTIGATION IS IN PROGRESS.

    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 CHOLECYSTECTOMY PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) #4 ALLEGEDLY DRIFTED AFTER THE SURGEON REMOVED HIS HEAD FROM THE SURGEON SIDE CONSOLE (SSC). A CADIERE FORCEPS INSTRUMENT WAS ENGAGED ON USM #4 AT THE TIME OF THE EVENT. THE SURGEON CLAIMED THAT HE REMOVED HIS HEAD FROM THE SSC AND THEN REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATORS (MTM). ACCORDING TO THE INITIAL REPORTER, THE MTM DRIFTED UNEXPECTEDLY, CAUSING USM #4 WITH THE CADIERE FORCEPS INSTRUMENT INSTALLED TO INJURE THE LIVER. A MINOR BREAK TO THE PARENCHYMA OF THE LIVER OCCURRED; HOWEVER, THE INJURY BECAME HEMOSTATIC IMMEDIATELY. IT IS UNCLEAR IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS. THE PATIENT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205366 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A

    Patients

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