BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18838359 · Received March 5, 2024

    Report

    Report Number
    2955842-2024-12096
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 9, 2024
    Report Date
    February 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    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

    AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE TIP COVER SLIPPED PARTIALLY OFF THE MONOPOLAR CURVED SCISSORS EXPOSING SOME OF THE ORANGE ELECTRICAL CIRCUIT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: REP. STATED THAT THE TIP COVER ISSUE WAS THAT IT SLIPPED OFF AND FELL INTO THE PATIENT. THE TIP COVER WAS RETRIEVED IN THE SAME PROCEDURE. THE PATIENT DID NOT COME BACK FOR ANY ADDITIONAL PROCEDURES. NO PATIENT INJURY OR HARM. THE PROCEDURE WAS ROBOTICALLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175921 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 N/A 10886874111045

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES