BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 11870468 · Received May 24, 2021

    Report

    Report Number
    3001845648-2021-00413
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 2 UNITS OF LOT C1776192 OF ECHO-HD-22-EBUS-O-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS PER IMAGES PROVIDED, NEEDLE APPEARS TO BE BROKEN DISTALLY. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 12TH MAY 2021. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: DEVICE 1 - NO DEFECT OBSERVED. SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. DISTAL END OF NEEDLE EXAMINE AND NO ISSUE OBSERVED. NO STYLET RETURNED. DEVICE 2 - DISTAL END OF NEEDLE BROKEN. KINK BELOW THE SHEATH EXTENDER. SHEATH EXTENDER ABLE TO RETRACT WITHOUT ISSUE. SHEATH EXTENDER UNABLE TO ADVANCE PASS PROXIMAL KINK. NEEDLE ABLE TO ADVANCE AND RETRACT WITH DIFFICULTY. DISTAL END OF NEEDLE EXAMINED AND DISTAL NEEDLE BREAK OBSERVED. FOLLOWING THE LABORATORY EVALUATION ADDITIONAL INFORMATION WAS REQUESTED TO AID INVESTIGATION AND TO CLARIFY IF THE ACTUAL COMPLAINT ISSUE RELATED TO DEVICE 1 FOR PR 329438 (MDR REF: 3001845648-2021-00413) WAS FOR A DISTAL NEEDLE BREAK OR FOR A DIFFERENT FAILURE AS NO DISTAL NEEDLE BREAK WAS OBSERVED IN THE LAB EVALUATION. FROM ADDITIONAL INFORMATION PROVIDED: "I HAVE ASKED HIM ¿ SORRY BUT HE CAN'T CONFIRM WHICH DEVICE RELATE TO THE PATIENT AND THE RELEVANT PR ADDITIONAL COMPLAINT FILE WAS OPENED TO CAPTURE THE PROXIMAL KINK BELOW SHEATH EXTENDER OBSERVED DURING LAB EVALUATION. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O-C OF LOT NUMBER C1776192 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS OCCURRED PREVIOUSLY WITH THIS LOT C1776192 HOWEVER THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT C1776192. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0110-6 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. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO ADVANCEMENT INTO A HARD LESION CAUSING THE DISTAL TIP OF THE NEEDLE TO BREAK. IT COULD ALSO BE DUE TORTUOUS ANATOMY REQUIRING FLEXED ENDOSCOPE POSITION AND EXTREME ANGULATION RESULTING IN THE DISTAL PART OF THE NEEDLE BREAKING. AS PER ADDITIONAL INFORMATION PROVIDED; 17. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? YES. 18. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? FLEXED. 19. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? YES. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NEEDLE TIP , SUCTIONED OUT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    CONFIRMATION RECEIVED (B)(6) 2021 REGARDING THE MANUFACTURER AND EXPIRY DATE OF THE DEVICE, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO REFLECT THIS INFORMATION IN SECTION D.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING EBUS PROCEDURE THE DOCTOR NOTICE THAT THE NEEDLE HAS BEEN BENDED/KINK. HE PULL OUT THE NEEDLE IMMEDIATELY AND SAW THAT IT IS BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NEEDLE TIP, SUCTIONED OUT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767136 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1776192 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention