BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17955164 · Received October 18, 2023

    Report

    Report Number
    2955842-2023-19328
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    June 23, 2023
    Report Date
    September 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111038
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAUTERY SPATULA TIP (TIP) AS AN UNREQUESTED RMA. ALTHOUGH THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS PRODUCT, AN INVESTIGATION WAS COMPLETED. VISUAL INSPECTION OF THE ACCESSORY FOUND THERMAL DAMAGE AT THE PROXIMAL TIP (LOCATED AT THE BOTTOM). THE TIP EXHIBITED SIGNS OF CHARRING AND MELTING, WHICH IS INDICATIVE OF ARCING FROM THE INSTRUMENT THAT WAS USED WHEN THE ACCESSORY WAS INSTALLED. NO PIECE WAS FOUND TO BE MISSING.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAUTERY SPATULA TIP (TIP) AS A DISCREPANT RMA ALONG WITH THE PRODUCT RETURNED UNDER PATIENT IDENTIFIER (B)(6) . THERE WAS NO ALLEGED MALFUNCTION OR PATIENT INJURY REPORTED AGAINST THIS PRODUCT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586942 NONE CAUTERY SPATUAL TIP NAY INTUITIVE SURGICAL, INC 400160-05 NA 10886874111038

    Patients

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