BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 19874302 · Received July 31, 2024

    Report

    Report Number
    9614641-2024-01539
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 29, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    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, A 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1 ESTABLISHMENT NAME: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH IS RELATED TO PATIENT IDENTIFIERS (B)(6). THE LITERATURE ARTICLE IS ATTACHED FOR FURTHER INFORMATION.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED A LITERATURE TITLED "RISK FACTORS AND TREATMENT STRATEGIES FOR CHOLECYSTITIS AFTER METALLIC STENT PLACEMENT FOR MALIGNANT BILIARY OBSTRUCTION: A MULTICENTER RETROSPECTIVE STUDY". BACKGROUND AND AIMS: CHOLECYSTITIS CAN OCCUR AFTER SELF-EXPANDABLE METALLIC STENT (SEMS) PLACEMENT FOR MALIGNANT BILIARY OBSTRUCTION (MBO), BUT THE BEST TREATMENT OPTION FOR CHOLECYSTITIS HAS NOT BEEN DETERMINED. HERE, WE AIMED TO IDENTIFY THE RISK FACTORS OF CHOLECYSTITIS AFTER SEMS PLACEMENT AND DETERMINE THE BEST TREATMENT OPTION. METHODS: INCIDENCE, TREATMENTS, AND PREDICTIVE FACTORS OF CHOLECYSTITIS WERE RETROSPECTIVELY EVALUATED IN 1084 PATIENTS WITH DISTAL MBO (DMBO) AND 353 PATIENTS WITH HILAR MBO (HMBO) WHO UNDERWENT SEMS PLACEMENT AT 12 INSTITUTIONS FROM JANUARY 2012 TO MARCH 2021. RESULTS: CHOLECYSTITIS OCCURRED IN 7.5%OF PATIENTS WITH DMBO AND 5.9% OF PATIENTS WITH HMBO. THE RECURRENCE RATE WAS SIGNIFICANTLY LOWER (PZ .043) AND THE RECURRENCE-FREE PERIOD SIGNIFICANTLY LONGER (P Z.039) IN ENDOSCOPIC PROCEDURES THAN IN PERCUTANEOUS PROCEDURES FOR CHOLECYSTITIS TREATMENT. EUS-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) WAS BETTER IN TERMS OF TECHNICAL SUCCESS, PROCEDURE TIME, AND RECURRENCE-FREE PERIOD THAN ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE. OBSTRUCTION ACROSS THE CYSTIC DUCT ORIFICE BY TUMOR (PZ.015) AND BY STENT (PZ.037) WERE INDEPENDENT RISK FACTORS FOR CHOLECYSTITIS IN DMBO. CASES WITH MULTIPLE SEMS PLACEMENTS (ODDS RATIO [OR], 11; 95%CONFIDENCE INTERVAL [CI], 0.68-190; PZ.091) AND WITH GALLBLADDER STONES (OR, 2.3; 95%CI ,0.92-5.6; PZ.075) HAD A HIGHER RISK FOR CHOLECYSTITIS IN HMBO. CONCLUSIONS: THE INCIDENCES OF CHOLECYSTITIS AFTER SEMS PLACEMENT FOR DMBO AND HMBO WERE SIMILAR. EUS-GBD IS THE OPTIMAL TREATMENT OPTION FOR PATIENTS WITH CHOLECYSTITIS AFTER SEMS PLACEMENT FOR MBO. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS CHOLECYSTITIS - 102 PATIENTS (MILD - 49 PATIENTS, MODERATE - 49 PATIENTS, SEVERE - 4 PATIENTS) MILD BILIARY PERITONITIS - 3 PATIENTS MODERATE BILIARY PERITONITIS - 1 PATIENT STENT MIGRATION - 1 PATIENT OF NOTE, 45% (22/49), 29% (14/49), AND 50% (2/4) OF MILD, MODERATE, AND SEVERE CHOLECYSTITIS CASES, RESPECTIVELY, WERE MANAGED BY CAREFUL MONITORING AND ANTIBIOTIC THERAPY, AND 27% (6/22), 36% (5/14), AND 50% (1/2) OF THOSE MILD, MODERATE, AND SEVERE CASES REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216872 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GF-UCT260 - ULTRASOUND GASTROVIDEOSCOPE| TJF-260V - DUODENOVIDEOSCOPE