BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 9553433 · Received January 6, 2020

    Report

    Report Number
    3001845648-2020-00013
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Report Date
    January 6, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K160229. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. ADDITIONAL CLARIFICATION WAS RECEIVED FROM THE REGIONAL MANAGER INVOLVED IN THIS COMPLAINT ON 29-JAN-2020 CONFIRMING THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS RELATED TO A PREVIOUS LOGGED COMPLAINT AND THIS COMPLAINT WAS OPENED IN ERROR. THE INITIAL COMPLAINT INFORMATION PROVIDED FOR THIS COMPLAINT INDICATED PATIENT INJURY. DESPITE NUMEROUS REQUESTS, NO PATIENT INJURY COULD BE CONFIRMED AND IT IS NOW BELIEVED THAT THE DAMAGE TO THE ENDOSCOPE WAS INTERPRETED AS PATIENT INJURY DUE TO THE RELATED CLAIM SUBMITTED FOR THIS COSTS OF THE REPAIR.

    Description of Event or Problem · 0

    WE CAN CONCLUDE THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS RELATED TO A PREVIOUS LOGGED COMPLAINT AND THIS COMPLAINT WAS OPENED IN ERROR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DR (B)(6) FROM (B)(6) CALLED TO INFORM THAT ONE OF THE ECHO TIP PRO CORE?! WAS USED IN A PROCEDURE WHERE A PATIENT GOT INJURED. THE HOSPITAL IS CHARGING COOK NOW FOR COMPENSATION (B)(6). COOK IN AMERICA CALLED HIM/ HIS COMPANY TO INVESTIGATE THE ROOT OF THE PROBLEM. DR (B)(6) IS A TECHNICAL INGENIEUR WHO NEEDS INFORMATION ABOUT OUR NEEDLES. HE WANTS TO KNOW IF THE NEEDLE THE DOCTOR USED MATCHES THE ULTRASOUND THEY HAVE AND IF WE INFORMED THEM ABOUT WHICH NEEDLES TO USE FOR WHICH ULTRASOUND. DR (B)(6) NEEDS A PAPER ABOUT THE DIFFERENT ECHO NEEDLES WE HAVE AND IF THEY ALL CAN USED FOR THE SAME ULTRASOUND. HOPE I MADE IT A BIT CLEAR:-) "PATIENT INJURY WAS INDICATED, POSSIBLY REQUIRING MEDICAL / SURGICAL INTERVENTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15684 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention