BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 17304828 · Received July 12, 2023

    Report

    Report Number
    3001845648-2023-00547
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    March 31, 2023
    Report Date
    July 25, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002315195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476 CANCELLATION IS BEING SUBMITTED AS THE EVENT NO LONGER MEETS REPORTING CRITERIA AS PER 'FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016) BASED ON INVESTIGATION CONCLUSONS ON 25-JUL-23.

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    CANCELLATION IS BEING SUBMITTED AS THE EVENT NO LONGER MEETS REPORTING CRITERIA AS PER 'FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016) BASED ON INVESTIGATION CONCLUSONS ON 25-JUL-23.

    Description of Event or Problem · 0

    THIS RECORD WAS INITIATED IN RELATION TO (B)(4) AS REQUESTED BY THE MANUFACTURER ON (B)(6) 2023. JIL01 UPDATED AS PER COMPLAINT FORM RECEIVED ON 5/4/23 JIL01: THE SYRINGE TAP CONNECTOR IS DEFORMED. THIS FILE WILL CAPTURE THE USER ERROR NOTED IN BELOW QUESTIONS 10. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? PROCEDURE WAS FINISHED WITH DEVICE USING CROOKED SYRINGE CONNECTOR 11. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL. THE CROOKED SYRINGE WAS IN THE PACK PRIOR TO REMOVAL. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802737 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2021880 10827002315195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown