BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22561048 · Received July 21, 2025

    Report

    Report Number
    2955842-2025-31012
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 30, 2025
    Report Date
    June 30, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE. WHEN THE PROCEDURE STARTED. TRIED TO ACTIVATE FENESTRATED BIPOLAR BUT COULD NOT ACTIVATE IT. THERE WAS NO DAMAGE OBSERVED TO THE CONDUCTOR/ENERGY CABLE. THERE WAS NO ENERGY AT ALL, NO SIGNS OF THERMAL DAMAGE, NO INSTRUMENT COLLISION AND NOTHING FELL INTO THE PATIENTS ANATOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE HAD BIPOLAR ACTIVATION ISSUE AND RESOLVED BY REPLACING THE INSTRUMENT DUE POTENTIAL INTERNAL WIRE 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
    2724618 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205 N/A

    Patients

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