BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 9932632 · Received April 7, 2020

    Report

    Report Number
    3005580113-2020-00349
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 20, 2012
    Report Date
    June 1, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D2) FCG KIT, NEEDLE, BIOPSY.

    Description of Event or Problem · 0

    PLEASE NOTE THIS REPORT WILL UPDATE THE RPN TO ECHO-HD-22-C.

    Additional Manufacturer Narrative · 1

    COMMON NAME: FCG KIT, NEEDLE, BIOPSY. PRODUCT CODE: FCG.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS VIA LITERATURE ARTICLE: TITLE OF LITERATURE REVIEW: 'RANDOMIZED TRIAL COMPARING THE 22-GAUGE ASPIRATION AND 22-GAUGE BIOPSY NEEDLES FOR EUS-GUIDED SAMPLING OF SOLID PANCREATIC MASS LESIONS' BANG ET AL 2012. 'ONLY 2 PATIENTS IN THE ENTIRE COHORT HAD COMPLICATIONS: 1 PATIENT (3.6%) IN THE FNA GROUP HAD POSTPROCEDURAL ABDOMINAL PAIN THAT WAS MANAGED CONSERVATIVELY ON AN OUTPATIENT BASIS, AND 1 PATIENT (3.6%) IN THE FNB COHORT DEVELOPED MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS.' THIS FILE IS CREATED TO CAPTURE 1 PATIENT (3.6%) IN THE FNB COHORT DEVELOPED MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS.' PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE MILD ACUTE PANCREATITIS , THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: 22 G FNB NEEDLE (ECHOTIP PRO CORE) COULD INCLUDE: ITF052-EN EBUS NEEDLES: ECHO-HD-22-EBUS-O - C OR ITF039-AN ASPIRATION NEEDLES: ECHO-HD-22-C. AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER¿S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396544 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization