BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 12257276 · Received August 1, 2021

    Report

    Report Number
    8010047-2021-09585
    Event Type
    Malfunction
    Date Received
    August 1, 2021
    Report Date
    September 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS KOREA (OKR). OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENA (THE INSERTION SECTION COATING PEELING AND THE INSTRUMENT CHANNEL PORT LOOSENING) COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OKR AND SIMILAR PAST CASES, OMSC SURMISED THAT THE INSERTION SECTION COATING PEELING WAS ATTRIBUTED TO THE FOLLOWING. - DURING USE OR CLEANING, EXTERNAL FORCE WAS APPLIED BY RUBBING THE SURFACE OF THE INSERTED SECTION STRONGLY, AND THE COATING OF THE INSERTION SECTION PEELED OFF. - THE COATING OF THE INSERTION SECTION WAS WORN OUT AND PEELED OFF DUE TO LONG-TERM USE. IN ADDITION, OMSC SURMISED THAT THE REPORTED INSTRUMENT CHANNEL PORT LOOSENING WAS ATTRIBUTED TO THE FOLLOWING. - DURING USE OR CLEANING, EXTERNAL FORCE WAS APPLIED BY HITTING THE INSTRUMENT CHANNEL PORT, OR REMOVING THE INSTRUMENT TOOLS AND CLEANING BRUSHES STRONGLY, AND THE INSTRUMENT CHANNEL PORT WAS LOOSENED. - THE ADHESIVE OF THE FIXING PART OF THE INSTRUMENT CHANNEL PORT WAS WORN OUT DUE TO LONG-TERM USE, AND THE INSTRUMENT CHANNEL PORT WAS LOOSENED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENA. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF MORE THAN 1MM2 AND THE INSTRUMENT CHANNEL PORT HAD BEEN LOOSENED DURING THE INCOMING INSPECTION OF THE SUBJECT DEVICE FOR THE REPAIR AT OLYMPUS (B)(4). THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154378 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1