BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 3054906 · Received April 4, 2013

    Report

    Report Number
    8010047-2013-00084
    Event Type
    Other
    Date Received
    April 4, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT, AND WAS INFORMED THAT THE BLEEDING WAS STOPPED USING A XYLOCAINE MIXED WITH ADRENALINE AND THROMBIN AND THE PT RECEIVED BLOOD TRANSFUSIONS. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE FORCEPS CUPS OF THE SUBJECT DEVICE CLOSED EVENLY AND WERE PROPERLY ALIGNED AND THAT THERE WERE NO ABNORMALITIES IN THE CUTTING EDGES OF THE CUPS. THERE WERE ALSO NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE MANUFACTURING RECORD OF THE SUBJECT DEVICE. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. DOING SO COULD CAUSE PT 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 A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN BRONCHOSCOPY, THE SUBJECT DEVICE CAUSED BLEEDING IN THE TARGET SITE. THE BLEEDING WAS REPORTEDLY TREATED WITH AN UNCERTAIN MEANS. AND THE PROCEDURE WAS ABANDONED. THE PT WAS REPORTEDLY DOING FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137514 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS FCL OLYMPUS MEDICAL SYSTEMS CORP FB-211D T28205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other