BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 14734854 · Received June 17, 2022

    Report

    Report Number
    8010047-2022-10261
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 18, 2022
    Report Date
    August 3, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K910423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 ARTICLE: FLEXIBLE BRONCHOSCOPY: THE FIRST-CHOICE METHOD OF REMOVING FOREIGN BODIES FROM THE AIRWAYS OF CHILDREN BY EVELISE LIMA, BIANCA FIDELIX ESPINDOLA, ISADORA OLIVEIRA MORAIS, PAULO ROGÉRIO SCORDAMAGLIO, ASCÉDIO JOSÉ RODRIGUES. WE PRESENT OUR EXPERIENCE USING THERAPEUTIC FB AS THE FIRST-CHOICE METHOD OF REMOVING AFBS IN CHILDREN. WE PERFORMED A RETROSPECTIVE STUDY OF PEDIATRIC PATIENTS (UNDER 18 YEARS OF AGE) WHO UNDERWENT BRONCHOSCOPY FOR AFB REMOVAL AT THE RESPIRATORY ENDOSCOPY DEPARTMENT OF THE UNIVERSITY OF SÃO PAULO SCHOOL OF MEDICINE HOSPITAL DAS CLÍNICAS HEART INSTITUTE, LOCATED IN THE CITY OF SÃO PAULO, BRAZIL, BETWEEN JANUARY OF 2014 AND JUNE OF 2020. WE REVIEWED MEDICAL AND BRONCHOSCOPY RECORDS AND COLLECTED INFORMATION ABOUT THE EQUIPMENT USED, FOREIGN BODY LOCATION/NATURE, AGE, SEX, SUCCESS RATE, AND COMPLICATIONS. ALL PATIENTS UNDERWENT FB TO LOCATE THE AFB IN THE TRACHEOBRONCHIAL TREE, EVALUATE THE DEGREE OF INFLAMMATION OR SUPPURATION OF THE TRACHEOBRONCHIAL MUCOSA, AND CHOOSE THE EQUIPMENT THAT WAS NECESSARY FOR THERAPEUTIC MEASURES. RIGID BRONCHOSCOPY WAS AVAILABLE FOR IMMEDIATE USE IN CASE OF FB FAILURE. THE PROCEDURES WERE PERFORMED IN THE OPERATING ROOM UNDER SEDATION OR GENERAL ANESTHESIA. ONE PERCENT LIDOCAINE WITHOUT A VASOCONSTRICTOR WAS USED AS A TOPICAL ANESTHETIC ON THE AIRWAYS, WITH THE MAXIMUM DOSE BEING 4 MG/KG. ALL PATIENTS WERE MONITORED WITH OXIMETRY, CARDIAC MONITORING, AND NONINVASIVE ARTERIAL PRESSURE MEASUREMENT. ADVERSE EVENTS: COMPLICATIONS OCCURRED IN 3 CASES (7.5%). ONE OF THEM WAS A MINOR COMPLICATION¿RIGHT MAIN BRONCHUS LACERATION DURING REMOVAL. THERE WERE 2 CASES OF MAJOR COMPLICATIONS: 1 OF RESPIRATORY FAILURE AND 1 OF CARDIAC ARREST (BOTH CASES REQUIRED OROTRACHEAL INTUBATION). NO DEATHS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202189 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-P30

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other