BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18466827 · Received January 8, 2024

    Report

    Report Number
    2955842-2023-21964
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 4, 2023
    Report Date
    December 14, 2023
    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
    003

    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. THE INSTRUMENT WAS FOUND WITH A BROKEN CURVED BLADE. THE BROKEN PIECE, APPROXIMATELY 0.19" X 0.10" WAS RETURNED. NO MATERIAL APPEARED TO BE MISSING AS THE BROKEN ASSEMBLY WAS PIECED BACK TOGETHER. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD CONTACT WITH THE ASPIRATOR. AFTER THE CONTACT WITH THE ASPIRATOR, THE GENERATOR INDICATED THE NEED FOR DECOMPRESSION. THE ASSISTANT REMOVED THE INSTRUMENT AND SCRUBBED THE BLADE, THE BLADE BROKE WHEN USED AGAIN. THE CUSTOMER USED ANOTHER INSTRUMENT OF THE SAME KIND TO COMPLETE THE PROCEDURE. FRAGMENTS WERE REPORTED TO HAVE FALLEN INSIDE THE PATIENT AND WERE RETRIEVED FROM THE BODY DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING OUT OF THE ORDINARY. THE ISSUE HAPPENED AS THE SURGEON WAS DISSECTING TISSUE. THE SURGEON BELIEVES WHAT CAUSED THE ISSUE IS A QUALITY PROBLEM AND HE FELT THAT THE COLLISION IN FRONT WAS NOT ENOUGH TO DAMAGE THE INSTRUMENT. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE, THE WRIST WAS STRAIGHTENED BEFORE THE REMOVAL. THE SURGEON AND HIS ASSISTANT WORKED THROUGH AN ENDOSCOPE TO REMOVE THE FRAGMENT. NO ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601117 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L80230202 0154 10886874112738

    Patients

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