BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23823972 · Received December 16, 2025

    Report

    Report Number
    2955842-2025-47369
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    March 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, AND H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE UPPER JAW. TWO BROKEN PIECES MEASURING APPROXIMATELY 1.60MM X 8.72MM AND 2.19MM X 3.57MM IN SIZE WERE IDENTIFIED, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT AND WAS RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. THE UPPER JAW IS STILL ATTACHED TO THE INSTRUMENT DUE TO THE BIPOLAR CONDUCTOR CABLE HOLDING IT INTACT. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO DAMAGE. THE INPUTS WERE MANUALLY ARTICULATED, AND THE ROLL, JOGGLE, PITCH AND YAW WENT TO THE RIGHT DIRECTIONS. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER COMPLAINT WAS THAT THE INSTRUMENT WAS FOUND TO HAVE DETACHED FRAGMENTS FROM THE BROKEN MOLDED INSULATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE EVENT OCCURRED WHILE THE SURGEON WAS PERFORMING DISSECTION. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED BY THE SURGEON DURING THE SAME SURGICAL PROCEDURE. THE SURGEON CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. NO ADDITIONAL SURGICAL PROCEDURE, SUCH AS LAPAROSCOPY OR OPEN SURGERY, WAS REQUIRED, AND NO POST-OPERATIVE IMAGING TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP INSTRUMENT OF THE SAME TYPE. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75011 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-62 K10250327 0007 00886874114339

    Patients

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