BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 22748405 · Received August 8, 2025

    Report

    Report Number
    2955842-2025-33345
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW, WITH BROKEN PIECES MEASURING APPROXIMATELY 3.50 MM BY 8.68 MM, WHICH WERE 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 THE SITE INCLUDE DETACHED FRAGMENTS RESULTING FROM THE BROKEN MOLDED INSULATOR. PIECES OF THE INSULATOR BROKE OFF AND WERE NOT RETURNED WITH THE INSTRUMENT. ADDITIONALLY, THE GRIP OF THE LOWER JAW BECAME DISLODGED DUE TO THE BREAK, AND THE LOWER GRIP WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END, LIKELY DUE TO THE BREAK IN THE MOLDED INSULATOR. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. FURTHERMORE, THE INSTRUMENT EXHIBITED THERMAL DAMAGE ON THE MOLDED INSULATOR OF THE UPPER JAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, THE JAWS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FELL APART WHILE INSIDE OF THE PATIENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999337 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-62 K13240801 0012 00886874114322

    Patients

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