BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 12768090 · Received November 8, 2021

    Report

    Report Number
    8010047-2021-14245
    Event Type
    Injury
    Date Received
    November 8, 2021
    Report Date
    November 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    UDI-DI
    04953170381928
    PMA / PMN Number
    K050503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. ON OCTOBER 28TH, THE MEDICAL SAFETY OFFICER, WHO HAVE THE MEDICAL LICENSE, REVIEWED AS BELLOW. THE HEMOTHORAX MIGHT BE SERIOUS INJURY BECAUSE THE PATIENT WAS REQUIRED ADDITIONAL HOSPITALIZATION AFTER EBUS-TBNA. IN ADDITION, IT ESTIMATED THAT THE PATIENT WAS HIGH RISK BECAUSE HE HAD EACH CANCER IN THE BRONCHUS AND THE COLON.

    Description of Event or Problem · 0

    ON OCTOBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "HEMOTHORAX AFTER ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION¿. THE PURPOSE OF THE LITERATURE WAS TO REPORT A CASE OF HEMOTHORAX AFTER ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IN A PATIENT WITH A RIGHT UPPER LOBE MASS. THE EBUS-TBNA WAS PERFORMED USING A BRONCHOSCOPE (BF-UC160F) AND A NEEDLE (NA-201SX-4022). IN THE LITERATURE, IT WAS REPORTED A CASE OF HEMOTHORAX 24 HOURS AFTER EBUS-TBNA AS BELLOW. ¿TWENTY-FOUR HOURS AFTER THE PROCEDURE THE PATIENT COMPLAINED OF INCREASING DYSPNEA AND RIGHT-SIDED PLEURITIC CHEST PAIN. HEMOGLOBIN FELL TO 49 G/L AND A CT SCAN SHOWED A HIGH ATTENUATION RIGHT-SIDED PLEURAL EFFUSION (FIG. 2). A DIAGNOSTIC THORACOCENTESIS REVEALED A BLOODY PLEURAL EFFUSION WITH PLEURAL FLUID HEMATOCRIT >50% OF THE PERIPHERAL BLOOD HEMATOCRIT (0.18 VS. 0.22) CONFIRMING THAT A HEMOTHORAX WAS PRESENT, AND A CHEST TUBE WAS PLACED WITH COMPLETE RECOVERY WITHIN 3 DAYS.¿ AFTERWARD, UNDERSTANDING A COLONOSCOPY, HE WAS DIAGNOSED WITH ADVANCED, STAGE IV LUNG ADENOCARCINOMA, AND SYNCHRONOUS SIGMOID ADENOCARCINOMA ARISING FROM TUBULOVILLOUS ADENOMA. CHEMOTHERAPY WAS STARTED AND MULTIPLE TRANSFUSIONS WERE REQUIRED DUE TO ANEMIA AND THROMBOCYTOPENIA SECONDARY TO HYPERSPLENISM. THE OUTCOME OF THE PATIENT WAS DEATH 2 MONTHS AFTER DIAGNOSIS. ON OCTOBER 28TH, THE MEDICAL SAFETY OFFICER, WHO HAVE THE MEDICAL LICENSE, REVIEWED AS BELLOW. THE HEMOTHORAX MIGHT BE SERIOUS INJURY BECAUSE THE PATIENT WAS REQUIRED ADDITIONAL HOSPITALIZATION AFTER EBUS-TBNA. IN ADDITION, IT ESTIMATED THAT THE PATIENT WAS HIGH RISK BECAUSE HE HAD EACH CANCER IN THE BRONCHUS AND THE COLON. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, 1 CASE OF A HEMOTHORAX MIGHT BE SERIOUS INJURY. THIS IS THE REPORT REGARDING 1 CASE OF A HEMOTHORAX THAT MAY HAVE REQUIRED ADDITIONAL HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671918 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-201SX-4022 04953170381928

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization