BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 21536445 · Received March 6, 2025

    Report

    Report Number
    2955842-2025-05487
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    February 12, 2025
    Report Date
    February 12, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111543
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN RECEIVED A FOR-FAILURE ANALYSIS EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A BROKEN MOLDED PIN. ONE OF THE PINS THAT ARE MOLDED TO THE MONOPOLAR YAW PULLEY WAS MISSING AND NOT RETURNED WITH THE INSTRUMENT. THE BROKEN MOLDED PIN OF THE INSTRUMENT YAW PULLEY MEASURED APPROXIMATELY 1.55 MM X 1.45 MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PERICARDIAL SURGICAL PROCEDURE, PART OF THE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT TIP DETACHED AND FELL INTO THE PERICARDIUM OF THE PATIENT DURING PREPARATION. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING TWEEZERS DURING THE SAME OPERATION, WITH ALL PERSONNEL PRESENT CONFIRMING ITS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP PERMANENT CAUTERY SPATULA INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592615 ENDOWRIST;DAVINCI SI PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 420184-15 K10230831 130 00886874111543

    Patients

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