BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23971240 · Received January 6, 2026

    Report

    Report Number
    2955842-2025-50505
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    September 30, 2025
    Report Date
    January 5, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE. IT HAD CHARRING AND LOCALIZED MELTING ON BOTH YAW PULLEYS IN THE SPACE BETWEEN THE GRIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, DAMAGE OCCURRED AT THE TIP OF THE MARYLAND BIPOLAR FORCEPS DURING COAGULATION. A FRAGMENT INTO A PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE FIELD " FRAGMENT FALL INTO THE PATIENT" SECTION WAS INCORRECTLY MARKED AS "YES." THERE IS NO RISK OF ANY PARTS BREAKING OR FALLING INTO THE PATIENT. IN ADDITION, THE CUSTOMER DID NOT OBSERVE ANY ARCING DURING THE USE OF THE INSTRUMENT. PRIOR TO THE PROCEDURE, THE INSTRUMENT WAS INSPECTED, AND NO PROBLEMS, DAMAGE, OR ANYTHING OUT OF THE ORDINARY WERE FOUND DURING THIS EXAMINATION. THE THERMAL DAMAGE TO THE INSTRUMENT WAS FIRST OBSERVED INTRAOPERATIVELY, MEANING IT WAS NOTICED DURING THE SURGERY ITSELF. ACCORDING TO THE SURGEON, HE SUSPECTS THAT THERE IS A PROBLEM WITH THE INSTRUMENT WHICH LED TO THE THERMAL DAMAGE, ALTHOUGH HE DID NOT SPECIFY THE EXACT MECHANISM. THERE WAS NO COLLISION BETWEEN THE INSTRUMENT AND ANY ENERGY INSTRUMENT DURING THE PROCEDURE, AND NO ARCING WAS OBSERVED AT ANY POINT. AS A RESULT, THERE IS NO INFORMATION REGARDING WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF ARCING, WHAT OTHER INSTRUMENTS WERE IN USE, THE ORIGIN OF ARCING, OR THE SURGEON¿S OPINION ON THE CAUSE OF ARCING, SINCE NO ARCING EVENT ACTUALLY OCCURRED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35135 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K11241024 0158 00886874119792

    Patients

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