BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 7599661 · Received June 13, 2018

    Report

    Report Number
    8010047-2018-01138
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 17, 2018
    Report Date
    December 28, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION WITH THE BENDING SECTION RUBBER REMOVED THE DEVICE EVALUATION CONFIRMED THAT SEVERAL METAL FILAMENTS OF THE INNER PARTS OF THE BENDING SECTION RUBBER FRAYED AND BROKE. THE ANALYSIS OF THE FRACTURE SURFACE ON THE BROKE POINT OF THE METAL FILAMENTS INDICATED THAT THE METAL FILAMENT POSSIBLY BROKE DUE TO A FATIGUE BY REPEATED PHYSICAL STRESS. THE EVALUATION COULD NOT IDENTIFY WHEN THE METAL FILAMENTS FRAYED AND BROKE. THE INSTRUCTION MANUAL HAVE ALREADY INSTRUCTED ¿INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION TUBE INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, PEELING, SCRATCHING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODY, DROPOUT OF PARTS, ANY PROTRUDING OBJECTS OR OTHER IRREGULARITIES.¿ IN ADDITION, THE INSTRUCTION MANUAL WARNS; ¿TRANSNASAL INSERTION IS ACCOMPANIED BY THE RISK OF INFLAMMATION OF THE NASAL CAVITY. IF THIS HAPPENS, THE NASAL PASSAGE WILL BE CONSTRICTED, MAKING IT MORE DIFFICULT TO WITHDRAW THE ENDOSCOPE. IN THIS CASE, DO NOT USE FORCE TO WITHDRAW THE ENDOSCOPE BECAUSE PATIENT INJURY SUCH AS BLEEDING OR PERFORATION MAY RESULT.¿

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4) SALES & SERVICE CO.,LTD. (OCM) FOR EVALUATION. THE EVALUATION CONFIRMED A PROJECTION ON THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE AND A AIR LEAKAGE AROUND THE PROJECTION. IN ADDITION, AFTER THE DISASSEMBLING OF THE BENDING SECTION RUBBER, THE EVALUATION CONFIRMED THAT SEVERAL METAL FILAMENTS OF THE INNER PARTS OF THE BENDING SECTION RUBBER FRAYED AND BROKE AT THE LEAKAGE POINT. OCM REVIEWED THE SERVICE (REPAIR) HISTORY OF THE SUBJECT AND CONFIRMED FOLLOWING REPAIR RECORD BY OCM; ON (B)(6) 2017, THE INSERTION PORTION OF THE SUBJECT DEVICE WAS REPLACED DUE TO AN AIR LEAKAGE FROM THE INSTRUMENT CHANNEL, SCRATCHES ON THE INSERTION PORTION, AND WEAR AND TEAR OF THE INSERTION PORTION. ON (B)(6) 2018, THE BENDING SECTION RUBBER WAS REPLACED DUE TO THE LEAKAGE FROM BENDING SECTION RUBBER. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING UNSPECIFIED TRANSNASAL BRONCHOSCOPY BY THE FACILITY, THE RHINAL MUCOSA OF THE PATIENT WAS INJURED AND HAD A SMALL AMOUNT OF BLEEDING. THE PROCEDURE WAS CANCELLED AND THE BLEEDING WAS TREATED BY ASTRICTION USING GAUZE. IT WAS REPORTED THAT THE BLEEDING STOPPED FIVE MINUTES AFTER THE ASTRICTION AND THERE WAS NO COMPLICATION RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441905 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other