BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23811542 · Received December 15, 2025

    Report

    Report Number
    2955842-2025-47370
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874123447
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A BROKEN MOLDED INSULATOR ON THE UPPER JAW. THE BROKEN MOLDED INSULATOR LIKELY CAUSED THE GRIP TIP TO BE FULLY DETACHED. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. VISUAL INSPECTION WAS PERFORMED AND FOUND NO EXTERNAL DAMAGE TO THE HOUSING OR MAIN TUBE. THE INPUT DISKS WERE MANUALLY ARTICULATED WITH NO ISSUES. THE GRIP KNOB WAS ABLE TO ROTATE, ALLOWING THE GRIPS TO OPEN/CLOSE WITHOUT ANY ISSUES. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. FRAGMENTS WERE NOT RETURNED AND WERE LIKELY CAUSED BY THE BROKEN OVER MOLDED INSULATOR. THE ENTIRE UPPER GRIP TIP WAS DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE EVENT OCCURRED DURING INSTRUMENT REMOVAL. THE FRAGMENT(S) WERERRETRIEVED DURING THE SAME SURGICAL PROCEDURE BY IRRIGATION AND SUCTIONING. THEY WERE UNABLE TO CONFIRM THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING BACKUP FBF INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282653 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430151-02 K10250515 0011 00886874123447

    Patients

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