BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 3820060 · Received May 14, 2014

    Report

    Report Number
    8010047-2014-00215
    Date Received
    May 14, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 16, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THERE WERE NO DEFECTS IN THE SHAPE OF THE DISTAL END OF THE CUPS AND THE CUTTERS. ALSO, THE CUPS COULD OPEN AND CLOSE SMOOTHLY. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. THEREFORE, OMSC THINKS THAT THE USER HANDLING OR CONDITION OF THE PATIENT CONTRIBUTED TO THIS EVENT. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT " DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE.", "BIOPSY MAY CAUSE BLEEDING. IF YOU TAKE A LARGE SAMPLE OR PRESS THE INSTRUMENT'S DISTAL END AGAINST TISSUE EXCESSIVELY, THE RISK OF BLEEDING WILL INCREASE. PERFORM BIOPSY ON MINIMUM NECESSARY SPOTS ONLY." THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE PRODUCT HAD SHARP EDGE. DURING BIOPSY, A LARGE BLEEDING WAS CONFIRMED. THE DOCTOR TREATED IT BY USING 2 CLIPS. THERE WAS NO INJURY REGARDING OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288917 DISPOSABLE BIOPSY FORCEPS BIOPSY FORCEPS FCL OLYMPUS MEDICAL SYSTEMS CORPORATION FB-230U K3Y073

    Patients

    Seq Age Sex Outcome Treatment
    1