BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 10160689 · Received June 16, 2020

    Report

    Report Number
    8010047-2020-03408
    Event Type
    Injury
    Date Received
    June 16, 2020
    Report Date
    June 17, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    PMA / PMN Number
    K151738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES WHICH PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION RELATED TO THE COMPLICATION.

    Description of Event or Problem · 1

    ON MAY 20, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED ¿MULTICENTER, RANDOMIZED COMPARISON OF THE DIAGNOSTIC ACCURACY OF 19-GAUGE STAINLESS STEEL AND NITINOL-BASED NEEDLES FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY OF SOLID PANCREATIC MASSES¿. THE LITERATURE REPORTED THE RESULT OF THE DIAGNOSTIC VALUE OF THOSE TWO NEEDLE TYPES IN PATIENTS WITH A SOLID PANCREATIC LESION IN PROSPECTIVE MULTICENTER RANDOMIZED SINGLE-BLINDED STUDY. A TOTAL OF 41 CONSECUTIVE PATIENTS, WHO INDICATED FOR EUS-FNB OF A SOLID PANCREATIC MASS BETWEEN SEPTEMBER 2016 AND DECEMBER 2017, WERE ENROLLED IN THIS PROSPECTIVE STUDY. IN THE SUBJECT PROCEDURES, IT WAS REPORTED THAT ONE MALFUNCTION AND TWO MUCOSAL BLEEDING RELATED TO EUS-FNB OCCURRED. THE ONE MALFUNCTION WAS REPORTED THAT THE USER COULD NOT ADVANCE THE NEEDLE OUT OF THE ENDOSCOPE IN ORDER TO PERFORM THE PUNCTURE, AND THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE TWO BLEEDING CASES WERE REPORTED DURING THE PROCEDURE: ONE SELF-LIMITED MUCOSAL BLEEDING EPISODE AND ONE THAT REQUIRED APPLICATION OF A CLIP. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THE LITERATURE INDICATED THAT NA-220H-8019 OR NA-U200H-8019, NA-U200H-8019S MIGHT BE USED FOR THE EUS-FNB. WE COULD NOT FOUND WHICH BIOPSY NEEDLES WERE USED, AND WE DECIDE TO REPORT THE MODEL AS "BIOPSY NEEDLE". THIS IS A REPORT ON A MUCOSAL BLEEDING THAT REQUIRED APPLICATION OF A CLIP ASSOCIATED WITH A BIOPSY NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623826 SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other