BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 6068890 · Received November 1, 2016

    Report

    Report Number
    3001845648-2016-00305
    Event Type
    Injury
    Date Received
    November 1, 2016
    Report Date
    November 4, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342804
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STYLET WAS PARTIALLY INSERTED. THE NEEDLE WAS BROKEN AT THE NOTCH AND THE TIP MEASURED APPROXIMATELY 4.5 MM. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE WAS BROKEN. AS USAGE CONDITIONS CANNOT BE REPLICATED WITHIN THE LABORATORY SETTINGS, THE ROOT CAUSE FOR THE BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-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 (B)(4). A REVIEW OF THE MANUFACTURING RECORD FOR ECHO-HD-25-EBUS-P-C DEVICE OF LOT NUMBER C1259163 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT REPORT. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. IT WAS ORIGINALLY INDICATED THAT THE DEVICE INVOLVED IN THIS COMPLAINT WAS BEING RETURNED TO COOK (B)(4) FOR EVALUATION; THE DEVICE HAS NOT YET BEEN RECEIVED, HOWEVER, IF IT IS RETURNED, THE DEVICE WILL BE EVALUATED AND THE INVESTIGATION WILL BE UPDATED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-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 (B)(4). A REVIEW OF THE MANUFACTURING RECORD FOR ECHO-HD-25-EBUS-P-C DEVICE OF LOT NUMBER C1259163 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT REPORT. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. THE TIP OF THE NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT WHICH WAS RETRIEVED WITH FORCEPS. THE PHYSICIAN THEN USED ANOTHER ECHO-HD-25-EBUS-P-C DEVICE OF THE SAME LOT# AND THIS TIP BENT BUT DID NOT BREAK. THE PHYSICIAN THEN SWITCHED TO AN ECHO-HD-22-EBUS-P-C, LOT# C1256322, AND THE TIP OF THIS NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT AND WAS RETRIEVED WITH FORCEPS. A FOURTH NEEDLE, ECHO-HD-22-EBUS-P-C, LOT# C1254294, WAS OPENED AND THE TIP OF THIS DEVICE BENT BUT DID NOT BREAK. THE PHYSICIAN THEN CALLED THE DISTRICT MANAGER AND IT WAS SUGGESTED USE ANOTHER TYPE OF NEEDLE THEREFORE THE PHYSICIAN COMPLETED THE PROCEDURE WITH AN FNA NEEDLE. THE PHYSICIAN STATED THAT IT TOOK APPROXIMATELY ONE HOUR LONGER FOR THE PROCEDURE DUE TO THESE DIFFICULTIES. AS FOUR DEVICES WERE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEING SUBMITTED FOR EACH DEVICE. THIS REPORT REFERENCES THE FIRST DEVICE USED - NEEDLE BREAKAGE. REFERENCE ALSO REPORTS# 3001845648-2016-00306, 3001845648-2016-00307 & 3001845648-2016-00308.

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT WHICH WAS RETRIEVED WITH FORCEPS. THE PHYSICIAN THEN USED ANOTHER ECHO-HD-25-EBUS-P-C DEVICE OF THE SAME LOT# AND THIS TIP BENT BUT DID NOT BREAK.THE PHYSICIAN THEN SWITCHED TO AN ECHO-HD-22-EBUS-P-C, LOT# C1256322, AND THE TIP OF THIS NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT AND WAS RETRIEVED WITH FORCEPS. A FOURTH NEEDLE, ECHO-HD-22-EBUS-P-C LOT# C1254294, WAS OPENED AND THE TIP OF THIS DEVICE BENT BUT DID NOT BREAK. THE PHYSICIAN THEN CALLED THE DISTRICT MANAGER AND IT WAS SUGGESTED USE ANOTHER TYPE OF NEEDLE THEREFORE THE PHYSICIAN COMPLETED THE PROCEDURE WITH AN FNA NEEDLE. THE PHYSICIAN STATED THAT IT TOOK APPROXIMATELY ONE HOUR LONGER FOR THE PROCEDURE DUE TO THESE DIFFICULTIES. AS FOUR DEVICES WERE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEING SUBMITTED FOR EACH DEVICE. THIS REPORT REFERENCES THE FIRST DEVICE USED - NEEDLE BREAKAGE. REFERENCE ALSO REPORTS# 3001845648-2016-00306, 3001845648-2016-00307 & 3001845648-2016-00308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721155 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002342804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention