BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXISION BIOPSY NEEDLE

    MDR report key: 17009862 · Received May 26, 2023

    Report

    Report Number
    17009862
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    EOQ
    UDI-DI
    00886874115961
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLEXISION BIOPSY NEEDLE 21G, DURING BRONCHOSCOPY, HAD A FAILED SHEATH AND NEEDLE ON 3 SEPARATE NEEDLES. NEEDLES: #240930; LNN22002; EXP 09/30/2024; #240930; LNN22003; EXP 09/30/2024 AND #241031; LNN 22003; EXP 10/31/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916035 FLEXISION BIOPSY NEEDLE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ INTUITIVE SURGICAL, INC. 490103 LNN22002, LNN22003, LNN22003 00886874115961

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Female