BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 9463570 · Received December 12, 2019

    Report

    Report Number
    8010047-2019-04299
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    December 13, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. AS PART OF OUR INVESTIGATION, OMSC REVIEWED ALL OF THE COMPLAINTS FOR THE PERIOD, BUT THERE WAS NO RECORD ASSOCIATED WITH THE EVENT DESCRIBED IN THE ARTICLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "BRONCHOSCOPY VERSUS AN ENDOTRACHEAL TUBE MOUNTED CAMERA FOR THE PERI-INTERVENTIONAL VISUALIZATION OF PERCUTANEOUS DILATATIONAL TRACHEOSTOMY - A PROSPECTIVE, RANDOMIZED TRIAL (VIVAPDT)". THE LITERATURE REPORTED THE FOLLOWING PROCEDURES USING OLYMPUS BRONCHO FIBERSCOPRE MODEL BF-P60 ; THIS STUDY COMPARED AND EVALUATED BRONCHOSCOPY VERSUS AN ENDOTRACHEAL TUBE MOUNTED CAMERA FOR THE PERI-INTERVENTIONAL VISUALIZATION OF PDT (PERCUTANEOUS DILATATIONAL TRACHEOSTOMY) IN PATIENTS PROSPECTIVE, RANDOMIZED STUDY. THE MEAN PROCEDURE TIME IS 10.6 PLUS MINUS 8.2 MINUTES, MEAN VISUALIZATION SCORES (BRONCHOSCOPY): 4.0 (95% CI 4.0-4.0; P<0.001). ALL PATIENTS RECEIVED THE ASSIGNED INTERVENTION, AND PDT WAS COMPLETED WITH BRONCHOSCOPIC GUIDANCE. VISUALIZATION OF PDT WITH THE VST WAS NOT NON-INFERIOR TO GUIDANCE WITH BRONCHOSCOPY. BRONCHOSCOPIC TECHNIQUE ALLOWS FOR SUPERIOR VISUALIZATION. IN THE SUBJECT PROCEDURES, 1 CASE OF THE PNEUMOTHORAX REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT SUBJECT DEVICE AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. OMSC IS SUBMITTING ONE MDR ACCORDING TO THE NUMBER OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250630 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-P60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other