BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXISION BIOPSY NEEDLE, 21G

    MDR report key: 16276977 · Received February 1, 2023

    Report

    Report Number
    16276977
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 24, 2023
    Report Date
    January 24, 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

    EIGHT DEVICES: ION 21G TBNA NEEDLE FAILED TO DEPLOY DURING THE BRONCHOSCOPY CASE. THE NEEDLE USED DURING ROBOTIC BRONCHOSCOPY WOULD NOT DEPLOY FROM THE SHEATH. THE SECOND NEEDLE WAS OPENED AND USED. ION 21G BIOPSY NEEDLE DEPLOYED THRU THE SIDE OF THE SHEATH. REP PULLED PRODUCTS FROM THE SHELF FOR RETURN TO THE MANUFACTURER. TWO SEPARATE LOT NUMBERS: L220015 (3 DEVICES) AND L220017 (5 DEVICES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689954 FLEXISION BIOPSY NEEDLE, 21G BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ INTUITIVE SURGICAL, INC. 490103 L220015 00886874115961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown