BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA PLEURA VIDEOSCOPE

    MDR report key: 15216604 · Received August 12, 2022

    Report

    Report Number
    9610595-2022-00829
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    February 3, 2022
    Report Date
    December 5, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EWY
    PMA / PMN Number
    K013617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿EFFICACY, SAFETY, AND OPTIMAL TIMING OF SINGLE-TROCAR VIDEO-ASSISTED FLEXIBLE THORACOSCOPIC DEBRIDEMENT UNDER LOCAL ANESTHESIA FOR COMPLICATED PARAPNEUMONIC EMPYEMA¿¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING PLEURA VIDEOSCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS EVIS PLEURA VIDEOSCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS EVIS LUCERA PLEURA VIDEOSCOPES OBJECTIVE. THORACOSCOPIC DEBRIDEMENT UNDER LOCAL ANESTHESIA IS A USEFUL APPROACH FOR COMPLICATED PARAPNEUMONIC EFFUSION OR EMPYEMA (CPE) AND IS A LESS INVASIVE PROCEDURE THAN VIDEO-ASSISTED THORACOSCOPIC SURGERY UNDER GENERAL ANESTHESIA. THERE ARE VARIOUS METHODS OF THORACOSCOPIC DEBRIDEMENT UNDER LOCAL ANESTHESIA, ALTHOUGH THE OPTIMAL TIMING OF TREATMENT IS UNKNOWN. THE OBJECTIVE OF THIS STUDY WAS TO VERIFY THE EFFICACY AND SAFETY OF OUR VIDEO-ASSISTED FLEXIBLE THORACOSCOPIC DEBRIDEMENT (VAFTS-D) PROCEDURE UNDER LOCAL ANESTHESIA, AND TO INVESTIGATE THE CLINICAL FEATURES ASSOCIATED WITH THE SUCCESS OF VAFTS-D. METHODS THE STUDY INCLUDED 71 CONSECUTIVE PATIENTS WITH CPE WHO UNDERWENT VAFTS-D. THE PRIMARY OUTCOME WAS SUCCESS OF VAFTS-D. WE RETROSPECTIVELY ANALYZED THE EFFICACY AND SAFETY OF VAFTS-D FROM THE CLINICAL DATA OBTAINED FROM HOSPITAL MEDICAL RECORDS AND USED UNIVARIATE LOGISTIC ANALYSES TO IDENTIFY POTENTIAL PREDICTORS OF THE OUTCOME. RESULTS VAFTS-D WAS CONSIDERED SUCCESSFUL IN 62 OF 71 PATIENTS (87.3%). TWO OF THE REMAINING NINE PATIENTS DIED AND THE OTHER SEVEN PATIENTS REQUIRED SUBSEQUENT OPERATION UNDER GENERAL ANESTHESIA. COMPLICATIONS DUE TO VAFTS-D OCCURRED IN SIX PATIENTS (8.5%). DURATION OF EMPYEMA <10 DAYS (P = 0.024) AND NEGATIVE BACTERIAL CULTURE IN PLEURAL EFFUSION (P = 0.029) WERE INDEPENDENTLY ASSOCIATED WITH THE SUCCESS OF VAFTS-D BY UNIVARIATE LOGISTIC REGRESSION ANALYSIS. CONCLUSION VAFTS-D MIGHT BE AN ACCEPTABLE FIRST-LINE PROCEDURE IN PATIENTS WITH SUSPECTED CPE. VAFTS-D SHOULD BE PERFORMED AS EARLY AS POSSIBLE FOR A SUCCESSFUL OUTCOME, AND TO OBTAIN USEFUL INFORMATION ON THE PLEURAL CAVITY. COMPLICATIONS DUE TO VAFTS-D OCCURRED IN SIX PATIENTS (8.5%), INCLUDING LUNG INJURY WITHOUT PERSISTENT AIR LEAKAGE (N = 3), ACUTE RESPIRATORY DISTRESS SYNDROME (N = 2), AND PORT INSERTION INTO THE ABDOMINAL CAVITY (N=1). THE INJURY OCCURRED DURING PORT INSERTION IN ALL THREE PATIENTS WITH LUNG INJURY. HOWEVER, BLEEDING FROM THE LUNG PARENCHYMA STOPPED SPONTANEOUSLY, AND AIR LEAKAGE WAS NOT OBSERVED AFTER VAFTS-D. BOTH CASES WHO DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME IMPROVED WITHIN A FEW DAYS AFTER VAFTSD, ALTHOUGH ONE CASE REQUIRED MECHANICAL VENTILATION AND THE OTHER WAS MANAGED WITH NON-INVASIVE POSITIVE PRESSURE VENTILATION. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274246 EVIS LUCERA PLEURA VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE EWY AIZU OLYMPUS CO., LTD. LTF-260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other