BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22508349 · Received July 15, 2025

    Report

    Report Number
    2955842-2025-29287
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS AN ALLEGATION OF ARCING DURING THE PROCEDURE, AND THE INSTRUMENT DID NOT EXPERIENCE A LOSS OF CAUTERY. THE INSTRUMENT MOVED IN THE INTENDED DIRECTION WITH NO REPORTS OF ISSUES RELATED TO NON-INTUITIVE OR UNCONTROLLED MOTION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT SUDDENLY COULD NOT WORK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING EXPERIENCED NEITHER LOSS OF CAUTERY OF THE INSTRUMENT. THE INSTRUMENT COULD EXPERIENCE NON-INTUITIVE MOTION OR UNCONTROLLED MOTION. NO JAWS WERE STUCK ON TISSUE. SURGEON/OR WAS ABLE TO OPEN THE JAWS AND RELEASE THE TISSUE. NO INJURY TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE. NO FRAGMENTS FELL INTO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740577 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 K10241128 0378 00886874112359

    Patients

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