BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 10294082 · Received July 20, 2020

    Report

    Report Number
    8010047-2020-04584
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Report Date
    October 2, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    PMA / PMN Number
    K151738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE STERILE PACKAGE WAS OPENED. A BLACK FOREIGN OBJECT WHICH WAS NOT A COMPONENT OF THE SUBJECT DEVICE WAS ALSO RETURNED. A FOREIGN MATERIAL ADHERED TO THE TIP OF THE INSERTION PART. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE ROOT CAUSE COULD NOT BE IDENTIFIED BECAUSE THE STERILE PACKAGE WAS OPENED AND THERE WERE NO PROBLEMS WITH THE MANUFACTURING RECORDS.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    DURING INSPECTION BEFORE USE, THE FOREIGN OBJECT WAS FOUND IN THE STERILE PACKAGE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FOREIGN OBJECT IN THE SEALED STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758569 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-U200H-8022 9ZK

    Patients

    Seq Age Sex Outcome Treatment
    1