BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEACON NEEDLE

    MDR report key: 13935140 · Received March 29, 2022

    Report

    Report Number
    3004904811-2022-00004
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    October 9, 2021
    Report Date
    March 28, 2022
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: USEFULNESS OF A FORK-TIP NEEDLE IN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY FOR GASTRIC SUBEPITHELIAL LESIONS SOURCE: DIAGNOSTICS 2021, 11, 1883 PP1-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2015 TO 2021, A RETROSPECTIVE STUDY OF 79 PATIENTS 13 PATIENTS ON THE FORK TIP GROUP AND 66 PATIENTS ON THE FINE NEEDLE ASPIRATION GROUP COMPARED THE SAMPLE ADEQUACY AND DIAGNOSTIC ACCURACY OF AN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY FOR GASTRIC SUB EPITHELIAL LESIONS USING A FORK-TIP NEEDLE WITH AN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION USING UNSPECIFIED FINE-NEEDLE ASPIRATION NEEDLES. COMPLICATIONS RELATED TO THE FINE NEEDLE BIOPSY INCLUDED INFECTION IN THE TUMOR AFTER THE PROCEDURE OCCURRED IN ONE PATIENT IN THE FORK-TIP GROUP WHICH REQUIRED ANTIBIOTICS. A FEW DAYS AFTER THE PROCEDURE, A FEVER OF 37 AND ELEVATED C-REACTIVE PROTEIN OF 1.45 WERE OBSERVED, AND COMPUTER TOMOGRAPHY SHOWED A HYPO-ABSORPTION ZONE INSIDE THE SUB EPITHELIAL LESIONS. ON THE BASIS OF THESE FINDINGS, INTRATUMORAL INFECTION WAS SUSPECTED. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR ABOUT TWO WEEKS, AND THE FEVER AND C-REACTIVE PROTEIN LEVELS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890800 UNKNOWN BEACON NEEDLE BIOPSY NEEDLE FCG COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention