BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19243909 · Received May 3, 2024

    Report

    Report Number
    2955842-2024-14195
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    May 20, 2023
    Report Date
    April 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE. IT EXHIBITED LOCALIZED MELTING WITH A CRATER-LIKE HOLE APPROXIMATELY 0.12" X 0.10" AT THE SILICON OVERMOLD, WHICH IS INDICATIVE OF ARCING. THE MCS INSTRUMENT REQUIRES THE USE OF A TIP COVER TO PREVENT ENERGY FROM DISCHARGING ANYWHERE BUT AT THE INSTRUMENT¿S TIP.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS RETURNED WAS USED IN THE SAME PROCEDURE AND WAS RELATED TO THE SAME EVENT.

    Description of Event or Problem · 0

    THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS RETURNED WITH NO REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758553 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 L80220930 10886874111045

    Patients

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