BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21236143 · Received January 25, 2025

    Report

    Report Number
    2955842-2025-00848
    Event Type
    Malfunction
    Date Received
    January 25, 2025
    Date of Event
    December 23, 2024
    Report Date
    January 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE ON THE MOLDED INSULATOR LOCATED AT THE GRIP TIP. ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. FAILURE ANALYSIS FOUND THE SECONDARY FAILURE OF INDENTATIONS ON THE MOLDED INSULATOR TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED AND THE INSTRUMENT WAS FOUND TO HAVE MECHANICAL INDENTATIONS ON THE MOLDED INSULATOR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING THERE WAS A DAMAGED TIP ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500579 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-57 U10240307 0006 00886874114322

    Patients

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