BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 18345691 · Received December 18, 2023

    Report

    Report Number
    9614641-2023-01933
    Event Type
    Death
    Date Received
    December 18, 2023
    Date of Event
    May 16, 2023
    Report Date
    January 8, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380402
    PMA / PMN Number
    K180449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 EVENT 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. THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR. B5 UPDATED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, NO OLYMPUS DEVICE MALFUNCTION OCCURRED DURING ANY OF THE EVENTS.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY FOR MALIGNANT AFFERENT LOOP SYNDROME USING A FULLY COVERED METAL STENT: A MULTICENTER EXPERIENCE". LITERATURE SUMMARY BACKGROUND: ENDOSCOPIC-ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) CAN BE A NEW ALTERNATIVE FOR PATIENTS WITH MALIGNANT AFFERENT LOOP SYNDROME (MALS). HOWEVER, A FULLY COVERED SELF-EXPANDABLE METAL STENT (FCSEMS) HAS NOT BEEN WELL INVESTIGATED IN THIS SETTING. METHODS: THIS IS A MULTICENTER RETROSPECTIVE COHORT STUDY. CONSECUTIVE PATIENTS THAT UNDERWENT EUS-GJ USING A FCSEMS FOR MALS BETWEEN (B)(6) 2017 AND (B)(6) 2022 WERE ENROLLED. PRIMARY OUTCOMES WERE TECHNICAL AND CLINICAL SUCCESS RATES. SECONDARY OUTCOMES WERE ADVERSE EVENTS, RECURRENT SYMPTOMS, AND OVERALL SURVIVAL. RESULTS: TWELVE PATIENTS (MEDIAN AGE: 67.5 YEARS (INTERQUARTILE RANGE: 58¿74.8); 50% MALE) WERE INCLUDED. THE MOST COMMON PRIMARY DISEASE AND TYPE OF PREVIOUS SURGERY WERE PANCREATIC CANCER (67%) AND PANCREATODUODENECTOMY (75%), RESPECTIVELY. TECHNICAL SUCCESS AND CLINICAL SUCCESS WERE ACHIEVED IN ALL PATIENTS. PROCEDURE-RELATED ADVERSE EVENTS OCCURRED IN ONE PATIENT (8%) WITH MILD PERITONITIS. DURING A MEDIAN FOLLOW-UP OF 96.5 DAYS, ONE PATIENT (8%) HAD RECURRENT SYMPTOMS DUE TO THE EUS-GJ STENT DYSFUNCTION; INCLUDING BILIARY EVENTS UNRELATED TO THE EUS-GJ STENT, FIVE PATIENTS (42%) HAD RECURRENT EVENTS. THE MEDIAN OVERALL SURVIVAL WAS 137 DAYS. NINE PATIENTS (75%) DIED DUE TO DISEASE PROGRESSION. CONCLUSIONS: EUS-GJ WITH A FCSEMS SEEMS SAFE AND EFFECTIVE FOR MALS WITH HIGH TECHNICAL AND CLINICAL SUCCESS RATES AND AN ACCEPTABLE RECURRENCE RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ EVENT 1: DEATHS- 9 PATIENTS EVENT 2: MILD PERITONITIS -1 PATIENT THIS ARTICLE REQUIRES 2 COMPLAINTS: 1. (B)(6)/NA-U200H-8019/DEATHS 2. (B)(6)/NA-U200H-8019/AE (EVENTS OTHER THAN DEATH) THIS COMPLAINT IS (B)(6). IT WAS REPORTED THAT 9 PATIENTS DIED, BETWEEN 43¿265 DAY. ALL DEATHS EVENTS WERE DUE TO PROGRESSION OF THE UNDERLYING DISEASE AS MENTIONED BY THE AUTHOR IN THE LITERATURE STUDY. 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
    889294 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019 04953170380402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death SINGLE USE GUIDEWIRE G-260-2545A, SN-UNK.