BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23985277 · Received January 6, 2026

    Report

    Report Number
    2955842-2026-00411
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 6, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, BIOMED CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT MILD SPARKS WERE VISIBLE ON A BIPOLAR FORCEPS INSTRUMENT DURING ENERGY ACTIVATION THROUGH AN EXTERNAL CAUTERY DEVICE. THE SITE COMPLETED THE SURGERY USING ANOTHER EQUIVALENT INSTRUMENT, AND NO PATIENT INJURY WAS NOTED. TROUBLESHOOTING INVOLVED SUGGESTING A RETURN MATERIAL AUTHORIZATION (RMA) FOR THE AFFECTED INSTRUMENT AND COORDINATING FOLLOW-UP WITH CUSTOMER SUPPORT RESOURCES. ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45433 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K10250626 0403 00886874119808

    Patients

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