BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010047-2000-00001

    MDR report key: 259345 · Received January 13, 2000

    Report

    Report Number
    8010047-2000-00001
    Event Type
    Other
    Date Received
    January 13, 2000
    Date of Event
    December 2, 1999
    Report Date
    December 17, 1999
    Manufacturer
    OLYMPUS OPTICAL CO., LTD
    Product Code
    KOG
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL RISK MANAGER REPORTED THAT A 2 MM PIECE OF A DISPOSABLE BIOPSY VALVE BROKE OFF AND FELL INTO A PT DURING A BRONCHOSCOPY PROCEDURE AS A PHYSICIAN INSERTED A BIOPSY FORCEPS INTO THE SCOPE'S CHANNEL. THE PHYSICIAN WAS UNSUCCESSFUL IN HIS ATTEMPTS TO REMOVE THE PIECE. FURTHERMORE, THE PIECE WAS NEVER FOUND NOR OBSERVED IN THE BRONCHUS IN AN X-RAY FOLLOWING THE OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WAS NO ADVERSE OUTCOME RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOG OLYMPUS OPTICAL CO., LTD MAJ-210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1