BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 9563196 · Received January 8, 2020

    Report

    Report Number
    3001845648-2020-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 9, 2019
    Report Date
    December 10, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K160229. 1 UNIT OF LOT C1647316 OF ECHO-HD-22-EBUS-P-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. DAMAGE TO THE DISTAL PART OF THE SHEATH WAS ALSO OBSERVED. BASED ON WORST CASE IT IS ASSUMED THAT THE NEEDLE BROKE INSIDE THE PATIENT AND WAS REMOVED, HOWEVER, WE DON¿T NOT HAVE CONFIRMATION OF THIS INFORMATION, WE DO KNOW ¿THE MISSING PART HAS BEEN DISPOSED OF BY THE CUSTOMER¿, WE ALSO KNOW THAT NO ADDITIONAL PROCEDURE WAS REQUIRED FROM THE INFORMATION PROVIDED. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-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-P-C OF LOT NUMBER C1647316 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 C1647316. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, 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" AND "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE USE OF THE STYLET. 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 USER ERROR AS THE STYLET SHOULD NOT BE PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF THE NEEDLE INTO INTENDED TARGETED SITE. THIS MAY HAVE CAUSED THE NEEDLE BREAKAGE AND POSSIBLY THEN RESULTED IN THE DISTAL SHEATH DAMAGE. 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 MISSING PART OF THE NEEDLE WAS DISPOSED OF BY THE CUSTOMER. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    NEEDLE WENT TROUGH THE DISTAL PART SHEATH. AS PER CC FORM: WHEN THE NEEDLE WAS PUSHED FORWARD, THE CATHETER WAS PIERCED. THAT WAS NOT ANGLED AT THE TIME. THE ENDOSCOPE AND THE PATIENT REMAINED UNHARMED. THE COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2020 AND THE DISTAL END OF THE NEEDLE WAS CONFIRMED TO BE BROKEN. NO PART OF THE NEEDLE REMAINS IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM IF THE NEEDLE BROKE INSIDE / OUTSIDE THE PATIENT.

    Description of Event or Problem · 0

    NEEDLE WENT TROUGH THE DISTAL PART SHEATH. AS PER CC FORM: WHEN THE NEEDLE WAS PUSHED FORWARD, THE CATHETER WAS PIERCED. THAT WAS NOT ANGLED AT THE TIME. THE ENDOSCOPE AND THE PATIENT REMAINED UNHARMED.

    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

    NEEDLE WENT TROUGH THE DISTAL PART SHEATH. AS PER CC FORM: WHEN THE NEEDLE WAS PUSHED FORWARD, THE CATHETER WAS PIERCED. THAT WAS NOT ANGLED AT THE TIME. THE ENDOSCOPE AND THE PATIENT REMAINED UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28470 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34279 C1647316 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1