BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 10975092 · Received December 9, 2020

    Report

    Report Number
    3001845648-2020-00924
    Event Type
    Injury
    Date Received
    December 9, 2020
    Report Date
    December 16, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K160229. THIS SUPPLEMENT REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS THIS INCIDENT WAS REPORTED PREVIOUSLY THIS FILE NO LONGER MEETS THE REPORTING CRITERIA AS PER THE GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016).

    Description of Event or Problem · 0

    THIS FILE WAS CONSERVATIVELY CREATED TO CAPTURE A COMMENT THE CUSTOMER MADE THAT THIS 'OCCURRED WITH THE SAME PRODUCT BEFORE A WHILE AGO.¿ADDITIONAL INFORMATION RECEIVED 16-DEC-2020 CONFIRMING THAT THIS INCIDENT OCCURRED AROUND 3 YEARS AGO AND WAS REPORTED AT THE TIME. THIS SUPPLEMENT REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT.

    Additional Manufacturer Narrative · 1

    510(K): K160229. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NEEDLE SNAPPED DURING PROCEDURE AND HAD TO BE REMOVED. ENDOSCOPE HAD TO BE SENT FOR REST OF NEEDLE TO BE REMOVED. PATIENT OK. (SEPARATE FILE CREATED TO CAPTURE THIS) CUSTOMER MENTIONED, THIS OCCURRED WITH THE SAME PRODUCT BEFORE A WHILE AGO.¿ THIS FILE IS CREATED TO CAPTURE THE COMMENT MADE BY THE CUSTOMER THAT THIS ISSUE OCCURRED WITH THE SAME PRODUCT PREVIOUSLY. PLEASE BE INFORMED OF THE FOLLOWING: CUSTOMER MENTIONED, THIS OCCURRED WITH THE SAME PRODUCT BEFORE A WHILE AGO. WE DON¿T HAVE ANY COMPLAINT LODGED AGAINST THIS CUSTOMER THIS YEAR. PLEASE CONTACT THE CUSTOMER AND ASK IF THEY ARE OTHER COMPLAINTS THAT THEY WERE NOT REPORTED. THANK YOU. THIS FILE WAS CREATED TO CAPTURE THE CUSTOMER'S COMMENT THAT 'THIS OCCURRED WITH THE SAME PRODUCT BEFORE A WHILE AGO'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440963 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention