BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23707052 · Received December 3, 2025

    Report

    Report Number
    2955842-2025-47200
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 8MM FORCE BIPOLAR INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 8MM FORCE BIPOLAR INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO HAVE A BENT GRIP TANG, PREVENTING THE GRIPS FROM OPENING. THE GRIPS DID NOT SHOW CRACKING DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF 8MM FORCE BIPOLAR INSTRUMENT WERE NOT OPENING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE JAWS OF INSTRUMENT WERE SHUT AND DID NOT OPEN AGAIN AFTER THE PROCEDURE WAS COMPLETED. PATIENT INFORMATION COULD NOT BE SHARED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787395 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10250626 0182 00886874120767

    Patients

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