BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS PLEURA VIDEOSCOPE

    MDR report key: 14073649 · Received April 11, 2022

    Report

    Report Number
    8010047-2022-06031
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    May 11, 2018
    Report Date
    May 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EWY
    PMA / PMN Number
    K013617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    CORRECTION B3: EVENT DATE UPDATED TO REFLECT ONLINE PUBLICATION DATE OF SOURCE ARTICLE. 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 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "BEDSIDE PLEUROSCOPY IN THE INTENSIVE CARE UNIT" BY HEAN OOI.   THIS STUDY RETROSPECTIVELY ANALYZED THE DATA FROM A CONSECUTIVE CASE SERIES, AND EXAMINED THE COMPLICATIONS AND OUTCOMES FOLLOWING BEDSIDE PLEUROSCOPY IN PATIENTS WITH UNDIAGNOSED PLEURAL EFFUSION WITH ACUTE RESPIRATORY FAILURE. A TOTAL OF 25 PATIENTS UNDERWENT PLEUROSCOPIC PROCEDURES AT THE BEDSIDE, AND WERE ROUTINELY MONITORED AND RECORDED FOR ANY MAJOR AND MINOR COMPLICATIONS. THE STUDY REPORTED THAT FIFTEEN PATIENTS (60%) HAD MALIGNANCIES, OF WHOM 11 HAD LUNG CANCER, AND ONE EACH HAD BREAST CANCER, ESOPHAGEAL CANCER, HEPATOMA, AND A MALIGNANT MEDIASTINAL TUMOR. A TOTAL OF 11 (44%) PATIENTS SUFFERED ANY COMPLICATIONS, BUT NO MAJOR COMPLICATIONS WERE REPORTED. THE STUDY CONCLUDED THAT THE PLEUROSCOPY PERFORMED AT THE BEDSIDE IN AN ICU WITH LOCAL ANALGESIA WAS AN EASY AND WELL-TOLERATED PROCEDURE, AND COULD BE USED FOR PATIENTS IN CRITICAL CONDITION.     TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: SUBCUTANEOUS EMPHYSEMA - (3): ALL PATIENTS HAD 16 F PIG-TAIL CATHETHER DRAINS AFTER THE PROCEDURE THROUGH THE SAME ENTRY PORT AS THE PLEUROSCOPY TO AVOID THE SPREAD OF SUBCUTANEOUS EMPHYSEMA. HYPOTENSION (PERIPROCEDURE) - (1): NOTED DURING THE PROCEDURE WAS ALSO CORRECTABLE WITH ADEQUATE HYDRATION. THIS ARTICLE INCLUDES 2 REPORTS: PATIENT IDENTIFIER (B)(6): LTF-160, PATIENT IDENTIFIER (B)(6): LTF-240. THIS REPORT IS 2 OF 2 FOR PATIENT IDENTIFIER (B)(6): LTF-240.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488965 EVIS PLEURA VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE EWY OLYMPUS MEDICAL SYSTEMS CORP. LTF-240

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other