BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 8915357 · Received August 21, 2019

    Report

    Report Number
    3001845648-2019-00424
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 21, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. 1 UNIT OF LOT C1575166 OF ECHO-HD-22-EBUS-P-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE SHEATH WAS OBSERVED TO BE DETACHED FROM THE SHEATH HOLDER (MOULDED HUB) DURING THE INITIAL LAB EVALUATION. THE FLARE WAS OBSERVED TO BE PRESENT IN THE MOULDED HUB DURING THE LAB RE-EVALUATION. 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 C1575166 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 C1575166. 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". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE FAILURE OF SHEATH BROKEN WAS OBSERVED IN THE LABORATORY. 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 EXCESSIVE FORCE. THIS WOULD HAVE PREVENTED ADVANCEMENT/RETRACTION OF THE NEEDLE. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DESOLIDARISATION OF THE SHEATH DURING ITS FIRST USE (MOBILE SHEATH), THE NEEDLE COULD NOT GET OUT ANYMORE. CONSEQUENCES: BIOPSY NEEDLE NOT USABLE ANYMORE. ECHO ENDO. DURING THE LABORATORY EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2019 IT WAS NOTED THAT THE NEEDLE WAS UNABLE TO ADVANCE OR RETRACT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DESOLIDARISATION OF THE SHEATH DURING ITS FIRST USE (MOBILE SHEATH), THE NEEDLE COULD NOT GET OUT ANYMORE. CONSEQUENCES: BIOPSY NEEDLE NOT USABLE ANYMORE. ECHO ENDO. DURING THE LABORATORY EVALUATION OF THE RETURNED DEVICE ON 24-JUL-19 IT WAS NOTED THAT THE NEEDLE WAS UNABLE TO ADVANCE OR RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708302 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34279 C1575166 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1