BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 24286115 · Received February 7, 2026

    Report

    Report Number
    2955842-2026-03011
    Event Type
    Injury
    Date Received
    February 7, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 23, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874123461
    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

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE UPPER JAW. DUE TO THE BROKEN MOLDED INSULATOR, ONE OF THE ENTIRE GRIP TIPS APPEARED TO BE COMPLETELY DETACHED FROM THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. THE THREE BROKEN PIECES RETRIEVED MEASURED APPROXIMATELY 4.30MM X 15.17 MM, 1.38MM X 8.24MM AND 2.12MM X 2.13MM, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT AND WAS RETURNED WITH THE INSTRUMENT. 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. THE THREE DETACHED FRAGMENTS THAT WERE RETURNED MEASURED APPROXIMATELY 4.30MM X 15.17 MM, 1.38MM X 8.24MM AND 2.12MM X 2.13MM. THE DETACHED FRAGMENTS WERE THE GRIP TIP AND SOME PARTS WERE FROM THE MOLDED INSULATOR. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL BASE. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE CONDUCTOR WIRE WAS LIKELY BROKEN DUE TO THE MOLDED INSULATOR DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.

    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 TRANSAXILLARY THYROIDECTOMY PROCEDURE, A FRAGMENT FROM THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND BECAME LODGED IN TISSUE THAT WAS DISSECTED. THE FRAGMENT WAS RECOVERED ALONG WITH THE SOFT TISSUE OF THE THYROID NODULE, WHICH WAS ALREADY PLANNED FOR REMOVAL. THE SURGERY PROCEEDED USING A REPLACEMENT MARYLAND BIPOLAR FORCEPS INSTRUMENT. NO ADDITIONAL PROCEDURE WAS REQUIRED, AND NO POSTOPERATIVE IMAGING WAS PERFORMED. THE PATIENT HAS NOT EXPERIENCED ANY POSTOPERATIVE COMPLICATIONS. ADDITIONALLY, THE PATIENT'S CURRENT MEDICAL STATUS WAS NOTED AS GOOD. THE SURGEON DID NOT OBSERVE ANY FUNCTIONAL ISSUES WITH THE INSTRUMENT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346662 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430152-02 K10250731 0011 00886874123461

    Patients

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