BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 21012303 · Received December 24, 2024

    Report

    Report Number
    2955842-2024-23566
    Event Type
    Injury
    Date Received
    December 24, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR. BROKEN PIECES, MEASURING APPROXIMATELY 7.98MM X 2.31MM AND 2.13MM X 2.55MM WERE RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATIONS RELATED TO THE CUSTOMER REPORTED COMPLAINT: DUE TO THE BROKEN MOLDED INSULATOR, A DETACHED FRAGMENT WAS OBSERVED AND WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED GRIP TIP. THE DISLODGED GRIP TIP, MEASURING APPROXIMATELY 4.72MM X 15.33MM, WAS RETURNED WITH THE INSTRUMENT. THIS FAILURE IS LIKELY CAUSED BY THE BROKEN MOLDED INSULATOR. DUE TO THE DISLODGED GRIP TIP, A DETACHED FRAGMENT WAS OBSERVED AND WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. THE BREAK ON THE CONDUCTOR WIRE WAS LOCATED AT THE MOLDED INSULATOR. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN WIRE SHOWED DAMAGE. THE INSTRUMENT WAS TRANSFERRED TO ADVANCED FAILURE ANALYSIS (AFA) ENGINEERING FOR ADDITIONAL EVALUATION. PER AFA, THE GRIP BASE DID NOT APPEAR TO BE BENT ON THE GRIP WITH THE BROKEN MOLDED INSULATOR, AND THE GRIP WITH THE INTACT MOLDED INSULATOR DID NOT APPEAR TO EXHIBIT BENDING OR PHYSICAL DAMAGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED.

    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 OOPHORECTOMY PROCEDURE, WHILE CONTROLLING BLEEDING FROM AN OVARY, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALTHOUGH THE CAUSE OF THE BLEEDING FROM THE BLEEDING IS UNKNOWN, IT WAS REPORTED THAT THE BLEEDING WAS EXPECTED AND MINIMAL. NO BLOOD TRANSFUSION WAS REQUIRED OR ADMINISTERED. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE INSTRUMENT WAS IN USE FOR TWO HOURS PRIOR TO BREAKAGE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT BEFORE THE EVENT OCCURRED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL DURING THE PROCEDURE. THERE WAS NO RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND THERE WAS NO DAMAGE OBSERVED ON THE CANNULA. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY IN ORDER TO RETRIEVE THE INSTRUMENT FRAGMENT(S). IT WAS CONFIRMED VISUALLY THAT NO FRAGMENTS WERE LEFT BEHIND. THERE WERE NO POST OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT IS AVAILABLE FOR ISI EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498015 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-62 K11240816 0011

    Patients

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