BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21914085 · Received April 25, 2025

    Report

    Report Number
    2955842-2025-17123
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED 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. CORRECTION: REFER TO FIELD D. SUSPECT MEDICAL DEVICE FOR UPDATED PRODUCT INFORMATION.

    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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826519 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10231123 0259 00886874112342

    Patients

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