BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24225595 · Received January 30, 2026

    Report

    Report Number
    2955842-2026-02647
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 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 A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS, AND THE COMPLAINT WAS CONFIRMED. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. D. SUSPECT MEDICAL DEVICE PRODUCT INFORMATION AS UPDATED. G4. WAS UPDATED TO K214095. H4. WAS UPDATED TO 06/06/2024. H9. FIELD ACTION NUMBER WAS UPDATED TO: ISIFA2024-09-C. H10 RELATED REPORT NUMBER 1 WAS UPDATED TO: 2955842-2026-04192.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT 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
    285847 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10240606 0375 00886874119808

    Patients

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