BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 17078610 · Received June 7, 2023

    Report

    Report Number
    3001845648-2023-00449
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    April 27, 2023
    Report Date
    August 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K210476. THIS IS A CANCELLATION REPORT BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 14-AUG-2023. THIS COMPLAINT IS CREATED TO CAPTURE NEGATIVE FEEDBACK. DEVICE EVALUATION 1 UNIT OF LOT C2015155 OF ECHO-HD-22-EBUS-O-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. NO ANSWERS TO THE STANDARD QUESTIONS WERE RECEIVED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 19 JUNE 2023. NO ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. A VERY SMALL PIECE OF MATERIAL WAS RETURNED SEPARATELY TO THE DEVICE WHICH DOES NOT APPEAR TO BE ANY PART OF THE DEVICE (MAY BE BIOLOGICAL MATTER). THROUGH THE LAB EVALUATION IT WAS ESTABLISHED THAT THERE WAS NO ISSUE WITH THE RETURNED DEVICE. AS A RESULT, IT WAS ASSUMED THAT THE PIECE OF MATERIAL WHICH WAS RETURNED SEPARATELY IN A PLASTIC VIAL TO THE RETURNED DEVICE MAY HAVE THOUGHT TO HAVE BEEN THE DISTAL TIP OF THE NEEDLE BY THE USER BUT INSTEAD MAY HAVE BEEN BIOLOGICAL MATTER (COMPLAINT DESCRIPTION STATES THAT THE NEEDLE GOT STUCK INSIDE THE TISSUE WHICH MAY BACK UP THIS ASSUMPTION). THIS ASSUMPTION WAS ALSO ALIGNED WITH THE REP. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O-C OF LOT NUMBER C2015155 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0109 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0109). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. NO ROOT CAUSE DETERMINATION REQUIRED: FOR UNCONFIRMED COMPLAINTS WHERE THE CUSTOMER CLAIM IS NOT CONFIRMED THROUGH SUPPORTING EVIDENCE OR FOR NEGATIVE/POSITIVE FEEDBACK WHERE THE COMPLAINT IS BASED ON CUSTOMER OPINION.¿ THROUGH THE LAB EVALUATION IT WAS ESTABLISHED THAT THERE WAS NO ISSUE WITH THE RETURNED DEVICE. AS A RESULT, IT WAS ASSUMED THAT THE PIECE OF MATERIAL WHICH WAS RETURNED SEPARATELY IN A PLASTIC VIAL TO THE RETURNED DEVICE MAY HAVE THOUGHT TO HAVE BEEN THE DISTAL TIP OF THE NEEDLE BY THE USER BUT INSTEAD MAY HAVE BEEN BIOLOGICAL MATTER (COMPLAINT DESCRIPTION STATES THAT THE NEEDLE GOT STUCK INSIDE THE TISSUE WHICH MAY BACK UP THIS ASSUMPTION). THIS ASSUMPTION WAS ALSO ALIGNED WITH THE REP. SUMMARY: COMPLAINT CANNOT BE CONFIRMED AS THERE IS NO SUPPORTING EVIDENCE TO IDENTIFY THE COMPLAINT FAILURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO COMPLETION OF LAB EVALUATION ON 19-JUN-2023.

    Description of Event or Problem · 0

    TIP OF THE NEEDLE BROKE AND GOT STUCK IN THE TISSUE AS PER CC FORM: "THE PHYSICIAN TRIED TO PUNCTURE THE LYMPH NODE. THE TIP OF THE NEEDLE BROKE AND GOT STUCK INSIDE OF THE TISSUE. NEEDLE TIP WAS RECOVERED." PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE PATIENT/EVENT INFO - NOTES: THE ADDITIONAL QUESTIONS HAVE BEEN SENT TO PHYSICIAN.

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 14-AUG-2023. THIS COMPLAINT IS CREATED TO CAPTURE NEGATIVE FEEDBACK. BASED ON THE DEVICE EVALUATION AND COMPLETION OF THE INVESTIGATION INCIDENT NO LONGER MEETS THE CRITERIA AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605517 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2015155 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention