BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 21461411 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-01726
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112137
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA TO PERFORM FAILURE ANALYSIS. THE CANNULA WAS ANALYZED AND FOUND TO HAVE SCRATCH MARK DAMAGE AT THE DISTAL END OF THE CANNULA. THE SCRATCH MARKS WERE LOCATED INSIDE OF THE DARK GREY INK STRIP AT THE BOTTOM OF THE CANNULA. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI ALSO RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE SCRATCHES ON THE MAIN TUBE. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE INSTRUMENT WAS RETURNED WITH THE CORD CUT SO THE INSTRUMENT WAS NOT ABLE TO BE TESTED FOR SEALING/CUTTING FUNCTIONALITY. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY THROUGH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A SEPARATE MEDWATCH REPORT (MDR) WITH MFR REPORT #2955842-2024-24002 WAS SUBMITTED FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT METAL SHAVINGS THAT HAD COME OFF INSIDE THE PATIENT AND X-RAY THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE COATING/METAL SHAVINGS ON SHAFT OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT SCRAPED OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES REPRESENTATIVE (CSR) THAT WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE METAL SHAVINGS. IT IS UNKNOWN IF ALL THE SHAVINGS WERE RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED BUT THE RESULTS OF THE X-RAY ARE UNKNOWN. THE SURGEON REPORTED THAT THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407203 DA VINCI CANNULA, STANDARD, REUSABLE NAY INTUITIVE SURGICAL, INC 470002-08 VE200701 00886874112137

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES