BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23363307 · Received October 22, 2025

    Report

    Report Number
    2955842-2025-42438
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 26, 2025
    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
    TX, US
    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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND 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 MEASURES APPROXIMATELY 15.65MM X 4.63MM AND WAS RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. VISUAL INSPECTION WAS PERFORMED AND FOUND NO DAMAGE TO THE HOUSING OR MAIN TUBE. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO INTERNAL DAMAGES. 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 BIPOLAR INSTRUMENT'S CONDUCTOR WIRE WAS FOUND TO BE BROKEN. THE BROKEN WIRE WAS LIKELY CAUSED BY THE BROKEN OVER MOLDED INSULATOR. THE LOCATION OF THE WIRE IS ON THE SIDE WITH THE UPPER JAW. THE WIRE APPEARS STICKING OUT AND WOULD FAIL ELECTRICAL CONTINUITY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, WHEN THE SURGEON ATTEMPTED TO GRASP THE TISSUE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS MISSING. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED AS PLANNED. AN X-RAY WAS PERFORMED TO CONFIRM NO FRAGMENTS REMAINED INSIDE THE PATIENT. 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
    232585 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430151-02 K10250403 0002 00886874123447

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES