BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 6168957 · Received December 13, 2016

    Report

    Report Number
    3001845648-2016-00358
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 16, 2016
    Report Date
    January 11, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    PMA / PMN Number
    K121430
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT APPROXIMATELY 8 MM OF THE TOP OF A NEEDLE WAS RETURNED, IT WAS BLUNTED/DAMAGED. THE NEEDLE HAD BROKEN AT THE NOTCH AND THE VERY TIP OF THE NEEDLE WAS NOT RETURNED. AN IMAGE WAS RETURNED FOR REVIEW. ONE UNUSED SEALED DEVICE WAS ALSO RETURNED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE WAS BROKEN. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-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 RECORD FOR ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1176023 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) # K142688. THE COMPLAINT DEVICE IS AWAITING RETURN TO (B)(4) FOR EVALUATION. ON RETURN OF THE DEVICE A LAB EVALUATION WILL BE CARRIED OUT AND THE INVESTIGATION UPDATED. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, IT IS THEREFORE NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-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-3-20-C DEVICE OF LOT NUMBER C1176023 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS DOING A PROCEDURE ON FEMALE TO DETERMINE A LESION AT THE TAIL OF PANCREAS. THE FIRST PASS WAS COMPLETED SUCCESSFULLY. AT THE SECOND PASS THE TIP OF THE NEEDLE BROKE WHILE PUNCTURING THE MUCOSA. THE TIP DID NOT BREAK INTO THE LESION BUT IN THE WALL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH A FORCEPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS DOING A PROCEDURE ON FEMALE TO DETERMINE A LESION AT THE TAIL OF PANCREAS. THE FIRST PASS WAS COMPLETED SUCCESSFULLY. AT THE SECOND PASS THE TIP OF THE NEEDLE BROKE WHILE PUNCTURING THE MUCOSA. THE TIP DID NOT BREAK INTO THE LESION BUT IN THE WALL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH A FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821745 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention