BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 10927426 · Received December 1, 2020

    Report

    Report Number
    3001845648-2020-00903
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 22, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002520117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. 1 UNIT OF LOT C1700892 OF ECHO-HD-22-EBUS-O WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON (B)(6) 2020. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY APPROX. 1.5CM FROM THE NEEDLE TIP. THE STYLET WAS UNABLE TO BE INSERTED FULLY MOST LIKELY DUE TO THE DISTAL NEEDLE BREAK. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O 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 OF LOT NUMBER C1700892 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1700892. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0051-8 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. 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 COULD BE ATTRIBUTED TO NEEDLE PENETRATION OF THE TARGET SITE BEING DIFFICULT AS INDICATED IN THE ADDITIONAL INFORMATION WHICH COULD HAVE CAUSED THE DISTAL TIP OF THE NEEDLE TO BREAK. THIS IN TURN MAY HAVE CAUSED THE STYLET ADVANCEMENT ISSUE OBSERVED DURING THE LAB EVALUATION. 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. THE TIP OF NEEDLE WAS RETRIEVED BY FORCEPS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS A FOLLOW UP REPORT. THE LAB EVALUATION WAS DONE ON 03-DEC-2020. THE INVESTIGATION IS STILL ON ONGOING.

    Description of Event or Problem · 0

    THE INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO CAPTURE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USER ADVANCED THE DEVICE TO DESIRED POSITION AND THE NEEDLE TIP BROKEN DURING FIRST BIOPSY. USER RETRACTED THE BROKEN NEEDLE TIP FROM PATIENT'S FUNDUS OF STOMACH WITH FORCEPS IMMEDIATELY. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). FUNDUS OF STOMACH. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 2-4CM. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS 290. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? YES. WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE? 1. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391542 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1700892 10827002520117

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention