BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23209107 · Received October 3, 2025

    Report

    Report Number
    2955842-2025-40378
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW. THE BROKEN PIECE MEASURES APPROXIMATELY 4.67 MM X 7.88 MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE THAT THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE INSTRUMENTS MOLDED INSULATOR BROKE OFF FROM THE INSTRUMENT. THE BROKEN PIECE WAS NOT RETURNED. THE INSTRUMENT WAS FOUND TO HAVE AN INTACT JAW DETACHED. THE JAW ALSO BECAME DETACHED AS A RESULT OF THE BREAK IN THE MOLDED INSULATOR. THE DETACHED JAW WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WHERE THE MOLDED INSULATOR BROKE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE CONDUCTOR WIRE BROKE AS A RESULT OF THE BREAK ON THE MOLDED INSULATOR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS NOT BEEN RETURNED TO INTUITIVE FOR FAILURE ANALYSIS.

    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 BENIGN HYSTERECTOMY PROCEDURE, THAT THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. RETRIEVAL WAS CONFIRMED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITH A BACK-UP FENESTRATED BIPOLAR FORCEPS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278033 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430151-02 K10250515 0029

    Patients

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