BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 11647423 · Received April 12, 2021

    Report

    Report Number
    8010047-2021-04817
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    May 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K910423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2021-04817 AND CORRECT THE INITIAL REPORT. OLYMPUS RE-EVALUATED THE EVENT REPORTED IN THE INITIAL REPORT AND DETERMINED THAT THE FAILURE MODE IS NOT A MDR REPORTABLE MALFUNCTION FOR THE FOLLOWING REASONS:. THE REPORTED PHENOMENON WAS NOT A LOCK OF ANGULATION, BUT RATHER A PHENOMENON THAT THE BENDING SECTION DID NOT MOVE WHEN THE ANGULATION CONTROL LEVER WAS MOVED DUE TO THE ANGLE WIRE CUTTING. THE ANGULATION WAS NOT LOCKED BECAUSE THE BENDING ANGLE WAS BEING MEASURED WHEN THE DEVICE WAS INSPECTED BY OLYMPUS (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THERE WAS A LEAKAGE AT THE BENDING SECTION RUBBER DUE TO THE CUT. THE BENDING TUBE WAS DEFORMED. THE IMAGE GUIDE BUNDLE WAS DIRTY AND SPOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE. THERE WAS PLAY IN THE CONTROL LEVER. THERE IS POSSIBILITY THAT THE CONTROL OF THE BENDING TUBE WAS AFFECTED BY THE FACT THAT THE INSIDE OF THE BENDING TUBE WAS FLOODED AND CORRODED DUE TO THE BREAKAGE OF BENDING SECTION RUBBER. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT THE ANGLE WIRE WAS CUT AND THE BENDING SECTION OF THE DEVICE COULD NOT BE ANGULATED AND COULD NOT BE CONTROLLED AT ALL. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT ANGULATION BECAME LOCKED AND COULD NOT DISENGAGE DUE TO THE CUTTING OF THE ANGLE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546013 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-N20

    Patients

    Seq Age Sex Outcome Treatment
    1