BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 19925761 · Received August 7, 2024

    Report

    Report Number
    2955842-2024-17921
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CURVED SCISSORS INSTRUMENT WAS FOUND TO HAVE AN INSTRUMENT TUBE ADAPTER BROKEN. THE BROKEN PIECE WAS NOT RETURNED, MEASURING ROUGHLY 0.128" X 0.150" IN SIZE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A PIECE OF PLASTIC AT THE TIP WAS NOTICED MISSING ON A SINGLE-PORT MONOPOLAR CURVED SCISSORS INSTRUMENT. IT WAS UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579680 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-57 K10240222 0001 00886874114285

    Patients

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