BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 20530532 · Received October 25, 2024

    Report

    Report Number
    2955842-2024-21176
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114315
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CRACKED TUBE ADAPTER. NO MATERIAL APPEARS TO BE MISSING. INTUITIVE SURGICAL, INC. (ISI) ADDITIONAL OBSERVATIONS NOT REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BENT ELECTRICAL CONTACTS. NO MATERIAL APPEARS TO BE MISSING. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE TUBE ADAPTER. AN IN-HOUSE INSTRUMENT TIP WAS INSTALLED, AND THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY AND PASSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT HAD A CRACK AT THE TIP OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAIL WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569461 ENDOWRIST SP MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC 430007-55 S10190315 0011 00886874114315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES