BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24571865 · Received March 11, 2026

    Report

    Report Number
    2955842-2026-15742
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 14, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING OF BOTH BIPOLAR YAW PULLEYS, IN THE SPACE BETWEEN THE GRIPS. THE INSTRUMENT'S GRIPS WERE MANUALLY MANIPULATED, AND THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT REGARDING THERMAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CONFIRMED THE SOURCE WAS A MEDICAL ENGINEER. WHO WAS NOT PRESENT DURING THE PROCEDURE OR THE EVENT. THE CUSTOMER REPORTED "UNKNOWN" FOR MOST DETAILS, INCLUDING WHETHER THE INSTRUMENT WAS INSPECTED PRIOR TO USE, WHETHER ANY DAMAGE WAS OBSERVED, WHEN THE THERMAL DAMAGE WAS FIRST IDENTIFIED, THE SUSPECTED CAUSE OF THE THERMAL DAMAGE, AND WHETHER THERE WAS ANY COLLISION WITH ANOTHER ENERGY INSTRUMENT. INFORMATION REGARDING ARCING¿SUCH AS WHETHER IT OCCURRED, WHAT TASK WAS BEING PERFORMED AT THE TIME, WHICH INSTRUMENTS WERE IN USE, THE ORIGIN OF THE ARCING, AND ITS CAUSE¿WAS ALSO REPORTED AS UNKNOWN. THERE WAS NO PATIENT INJURY ACCORDING TO THE INITIAL INFORMATION. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631388 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K12241121 00886874119792

    Patients

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