BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 10016913 · Received May 1, 2020

    Report

    Report Number
    3001845648-2020-00274
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    March 18, 2020
    Report Date
    May 8, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510K # : K160229. DEVICE EVALUATION: 1 UNIT OF LOT C1557547 OF ECHO-HD-22-EBUS-O-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 17 APR 2020. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. THE DISTAL TIP OF THE NEEDLE WAS OBSERVED TO BE BROKEN. 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 C1557547 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 C1557547. THE INSTRUCTIONS FOR USE, IFU0109-6 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" AND "THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE TYPE OF SCOPE USED (IFU0109-6) ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE USER USED THE DEVICE WITH AN INCOMPATIBLE DEVICE, AS PER INFORMATION PROVIDED, A FUJI SCOPE WAS USED AND AS PER IFU ¿THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE¿, THEREFORE THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS NOT POSSIBLE TO KNOW HOW THE DEVICE PERFORMS WITH AN INCOMPATIBLE DEVICE THEREFORE THE DISTAL NEEDLE BREAK COULD HAVE BEEN INDUCED BY THE SCOPE. 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. THE BROKEN NEEDLE TIP WAS REMOVED BY THE BRONCHOSCOPE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE NEEDLE TIP WAS BROKEN AND DISLODGED FROM THE REST OF THE NEEDLE ASSEMBLY WHILE PRICKING THE RIGHT LOWER PARATRACHEAL LYMPH NODE. TIP THE NEEDLE WAS SEEN AT CARINA AFTER BREAKAGE AND IT WAS REMOVED BY THE BRONCHOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. TIP THE NEEDLE WAS SEEN AT CARINA AFTER BREAKAGE AND IT WAS REMOVED BY THE BRONCHOSCOPE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE NEEDLE TIP WAS BROKEN AND DISLODGED FROM THE REST OF THE NEEDLE ASSEMBLY WHILE PRICKING THE RIGHT LOWER PARATRACHEAL LYMPH NODE. TIP THE NEEDLE WAS SEEN AT CARINA AFTER BREAKAGE AND IT WAS REMOVED BY THE BRONCHOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. TIP THE NEEDLE WAS SEEN AT CARINA AFTER BREAKAGE AND IT WAS REMOVED BY THE BRONCHOSCOPE. 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
    482519 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1557547 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention