BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 21216806 · Received January 23, 2025

    Report

    Report Number
    2955842-2025-00626
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    December 25, 2024
    Report Date
    December 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CRACKED BLADE. REVIEW OF THE PROVIDED IMAGE WAS CONSISTENT WITH DAMAGE AT THE INSTRUMENT TIP. THE EVENT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE KNIFE HEAD WAS BROKEN. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS CHECKED PRIOR TO USE WITH NO PROBLEM OBSERVED. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE. A FRAGMENT FELL NEXT TO THE KNIFE HEAD AND WAS TAKEN OUT DIRECTLY. THERE WAS NO FURTHER INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931482 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L81231207 0300 10886874112738

    Patients

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