BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18830304 · Received March 4, 2024

    Report

    Report Number
    2955842-2024-12012
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    September 18, 2023
    Report Date
    February 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI HAS NOT RECEIVED A DEVICE TO PERFORM FAILURE ANALYSIS INVESTIGATIONS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE. .

    Description of Event or Problem · 0

    ON 08-FEB-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY MEDWATCH REPORT 1402760000-2023-8010 STATING: DURING A ROBOTIC MYOMECTOMY SURGERY, THE DISPOSABLE ROBOTIC SLEEVE CAME OFF THE ROBOTIC MONOPOLAR SCISSORS. A WIRE WAS NOTED TO BE STICKING OUT OF THE SIDE. A SMALL PIECE OF THE ORANGE SLEEVE ON THE INSTRUMENT WAS RIPPED. THE VENDOR REP WAS NOTIFIED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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
    195085 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-15 I84230601

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES