BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U401SX

    MDR report key: 16765401 · Received April 18, 2023

    Report

    Report Number
    9614641-2023-00533
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    December 21, 2022
    Report Date
    May 5, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170388323
    PMA / PMN Number
    K160098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE DOI: 10.1159/000528644 PROVIDED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FEASIBILITY OF MODIFIED ENDOBRONCHIAL ULTRASOUND-GUIDED INTRANODAL FORCEPS BIOPSY: A RETROSPECTIVE ANALYSIS." THE RETROSPECTIVE STUDY WAS TO ASSESS THE FEASIBILITY OF THE MODIFIED EBUS- INTRANODAL FORCEPS BIOPSY (IFB) TECHNIQUE, WHICH COMBINES STANDARD-SIZED FORCEPS WITH STANDARD ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) EQUIPMENT. A TOTAL OF 195 PATIENTS WERE INCLUDED. IFB WAS TECHNICALLY SUCCESSFUL IN 177 OF 195 CASES (90.8%). THE DIAGNOSTIC ACCURACY WAS 99.5% (193 OF 194 CASES). ONE PATIENT WAS LOST TO FOLLOW-UP. UNIVARIABLE ANALYSES DID NOT IDENTIFY ANY FACTORS INVOLVED IN TECHNICAL IFB FAILURE. AMONG THE DIAGNOSED CASES, THREE (1.5%) WERE DIAGNOSED. THE MEDIAN (RANGE) HISTOLOGICAL SCORES OF TBNA AND IFB SPECIMENS WERE 1.50 (0¿2) AND 1.67 (0¿2), RESPECTIVELY, WHICH WERE SIGNIFICANTLY DIFFERENT (P = 0.032). IN CONCLUSION, MODIFIED EBUS-IFB, COMBINING STANDARD-SIZED FORCEPS AND THE USUAL EQUIPMENT FOR EBUS TBNA, IS FEASIBLE WITH FEW MAJOR COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PNEUMONIA - 1 PATIENT, PNEUMOTHORAX REQUIRING THORACIC DRAINAGE - 1 PATIENT, MINOR BLEEDING - 25 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6):NA-U401SX-4022-A, (B)(6):FB-15C-1, (B)(6):BF-UC290F, (B)(6):BF-UC260FW. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625391 SINGLE USE ASPIRATION NEEDLE NA-U401SX SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U401SX-4022 UNKNOWN(LITERATURE) 04953170388323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O