BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 15294385 · Received August 25, 2022

    Report

    Report Number
    9614641-2022-00208
    Event Type
    Injury
    Date Received
    August 25, 2022
    Report Date
    October 6, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380440
    PMA / PMN Number
    K151738
    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. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H6, H10. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO MALFUNCTIONS WERE REPORTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY VERSUS HEPATICOGASTROSTOMY WITH ANTEGRADE STENTING FOR MALIGNANT DISTAL BILIARY OBSTRUCTION." LITERATURE SUMMARY: RECURRENT BILIARY OBSTRUCTION (RBO) IS A POSSIBLE COMPLICATION OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO). METHODS: WE RETROSPECTIVELY EVALUATED CONSECUTIVE PATIENTS WHO UNDERWENT EUS-HGS OR HGAS . THE TRBO, OVERALL SURVIVAL (OS), AND ADVERSE EVENT (AE) RATE WERE COMPARED BETWEEN THE GROUPS. RESULTS: THIS STUDY INCLUDED 96 PATIENTS (EUS-HGS, N = 58; HGAS, N = 38). THERE WAS A SIGNIFICANT DIFFERENCE IN THE CAUSE OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FAILURE AND THE HGS STENT TYPE BETWEEN THE GROUPS. CONCLUSIONS: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY PROLONGED THE TRBO COMPARED WITH EUS-HGS FOR BILIARY DRAINAGE IN PATIENTS WITH MDBO. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: RECURRENT BILIARY OBSTRUCTION - 20 PATIENTS. PERITONITIS - 5 PATIENTS. CHOLANGITIS - 2 PATIENTS. PANCREATITIS - 5 PATIENTS. BLEEDING - 2 PATIENTS. DEATH 10 DAYS AFTER ONSET OF SEPTIC SHOCK - 1 PATIENTS. PSEUDOANEURYSM - 2 PATIENTS. DEATH IN THE FOLLOW UP - 97 PATIENTS (NOT REPORTABLE). NA-U200H-8019S WAS SELECTED BECAUSE A 19-GAUGE VERSION OF THE EZ SHOT 3 PLUS WAS USED. THIS ARTICLE INCLUDES 6 COMPLAINTS AS FOLLOWS: (B)(6) :NA-U200H-8019S (SEPTIC SHOCK/DEATH). (B)(6) :NA-U200H-8019S (FOR ADVERSE EVENTS ONLY). (B)(6) :GF-UCT260 (SEPTIC SHOCK/DEATH). (B)(6) :GF-UCT260 (FOR ADVERSE EVENTS ONLY). (B)(6) :JF-260V (SEPTIC SHOCK/DEATH). (B)(6) :JF-260V (FOR ADVERSE EVENTS ONLY). THIS IS REPORT 2 OF 6 FOR (B)(6): NA-U200H-8019S (FOR ADVERSE EVENTS ONLY).

    Description of Event or Problem · 0

    THE AUTHOR PROVIDED ADDITIONAL INFORMATION: THE OLYMPUS SERIAL/LOT NUMBERS ARE UNKNOWN. THE ADVERSE EVENTS AND DEATHS WERE NOT CAUSE OR CONTRIBUTED BY AN OLYMPUS DEVICE. THE ADVERSE EVENTS AND DEATHS ARE ATTRIBUTED TO AN EXACERBATION OF THE DISEASE. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129491 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019S UNKNOWN(LITERATURE) 04953170380440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNK SERIAL:GF-UCT260,JF-260V,TJF-260V