BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 8508566 · Received April 12, 2019

    Report

    Report Number
    3001845648-2019-00154
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Report Date
    April 12, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE COMPLAINT INVESTIGATION AND AN UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. THE ECHO-HD-25-EBUS-O-C DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ECHO-HD-25-EBUS-O-C DEVICES COULD NOT BE PERFORMED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-EBUS-O-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS PART OF THE INVESTIGATION. THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER TO; " IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: ¿THE NEEDLE MUST BE RETRACTED INTO THE SHEATH AND THE THUMBSCREW IN THE SAFETY RING MUST BE LOCKED AT THE 0 CM MARK TO HOLD THE NEEDLE IN PLACE PRIOR TO INTRODUCTION, ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. FAILURE TO RETRACT THE NEEDLE MAY RESULT IN DAMAGE TO THE ENDOSCOPE.¿ IN THE INSTRUCTIONS FOR USE SECTION IT IS MENTIONED; ¿CAUTION: DURING NEEDLE ADJUSTMENT OR EXTENSION, ENSURE THE DEVICE HAS BEEN ATTACHED TO THE ACCESSORY CHANNEL OF THE ENDOSCOPE. FAILURE TO ATTACH THE DEVICE PRIOR TO NEEDLE ADJUSTMENT OR EXTENSION MAY RESULT IN DAMAGE TO THE ENDOSCOPE.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE FAILURE OF SCOPE DAMAGE WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE INFORMATION PROVIDED IS LIMITED AND NO DEVICE HAS BEEN RETURNED FOR EVALUATION. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO EXCESSIVE FORCE, WHILE IT WAS REPORTED THAT FORCE WAS NOT REQUIRED ON INSERTION OF THE DEVICE INTO THE SCOPE, FOR SCOPE DAMAGE TO HAVE OCCURRED WITH THE DEVICE THERE MUST HAVE BEEN SOME FORM OF RESISTANCE EITHER ADVANCING THE DEVICE THROUGH THE SCOPE OF REMOVING IT FROM THE SCOPE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. NO ADVERSE EFFECTS HAVE BEEN REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE COMPLAINT INVESTIGATION AND AN UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. AS REPORTED TO CUSTOMER RELATIONS, "CUSTOMER REPORTS SCOPE DAMAGE OCCURRING TWICE AFTER USING 2 COOK EBUS NEEDLES." REFERENCE ALSO REPORT# 3001845648-2019-00146.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS, "CUSTOMER REPORTS SCOPE DAMAGE OCCURRING TWICE AFTER USING 2 COOK EBUS NEEDLES." REFERENCE ALSO REPORT# 3001845648-2019-00146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301662 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1