BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTOP ULTRA ULTRASOUND ASPIRATION NEEDLE

    MDR report key: 2003677 · Received February 23, 2011

    Report

    Report Number
    3001845648-2011-00009
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    COOK IRELAND, LTD.
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION; THEREFORE, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE FOLLOWING INFORMATION IS THE ONLY INFORMATION RECEIVED TO-DATE: PATIENT HAD POST-BIOPSY BLEEDING AT THE BIOPSY SITES IN THE DUODENUM WITH HYPOTENSION, REQUIRING ENDO TREATMENT AND ADMISSION. DESPITE NUMEROUS ATTEMPTS FOR FURTHER INFORMATION RELATING TO THE EVENT OR THE CUSTOMER, COMPLAINT REPORTING FORM WAS NOT RECEIVED. HEMORRHAGE IS ONE OF THE POTENTIAL COMPLICATIONS OF ENDOSCOPIC ULTRASOUND NEEDLE BIOPSY AND IS LISTED IN OUR INSTRUCTIONS FOR USE. PRIOR TO DISTRIBUTION, ALL (B)(4) DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE INVOLVED IN THIS COMPLAINT RECORD COULD NOT BE CARRIED OUT AS THE LOT NUMBER WAS UNKNOWN. A REVIEW OF THE 2-YEAR COMPLAINTS HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THE REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. COMPLAINTS OF THIS NATURE WILL BE MONITORED FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE.

    Description of Event or Problem · 1

    PATIENT HAD POST-BIOPSY BLEEDING AT THE BIOPSY SITES IN THE DUODENUM WITH HYPOTENSION, REQUIRING ENDO TREATMENT AND ADMISSION. A 19 GAUGE PROCORE NEEDLE WAS USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOTOP ULTRA ULTRASOUND ASPIRATION NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND, LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R