BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXISION

    MDR report key: 16582000 · Received March 21, 2023

    Report

    Report Number
    16582000
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 14, 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

    DURING BRONCHOSCOPY, TWO 21G FLEXISION BIOPSY NEEDLES WERE USED. BOTH NEEDLES WOULD NOT SEPARATE FROM THE CATHETER WELL WHILE TRYING TO OBTAIN BIOPSIES, AND THEY COULD NOT BE FULLY ADVANCED INTO THE TARGET STATION. DEVICE 1: (B)(4), 240630, L220017, EXP: 6/30/2024. DEVICE 2: (B)(4), 240731, L220024, EXP: 7/31/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8894 FLEXISION BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ INTUITIVE SURGICAL, INC. 490103 L220017, L220024 00886874115961

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Female