BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16895139 · Received May 9, 2023

    Report

    Report Number
    9610595-2023-07240
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    February 20, 2022
    Report Date
    May 18, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE DOI: HTTPS://DOI.ORG/10.1155/2022/1606944 PROVIDED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EVALUATION OF ANTIREFLUX MUCOSECTOMY FOR SEVERE GASTROESOPHAGEAL REFLUX DISEASE: MEDIUM-TERM RESULTS OF A PILOT STUDY". THE AIM OF OUR STUDY WAS TO EVALUATE THE MEDIUM-TERM EFFICACY OF THE ANTIREFLUX MUCOSECTOMY (ARMS) TECHNIQUE FOR PATIENTS WITH SEVERE GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS (PROTON PUMP INHIBITORS (PPI)-TREATMENT-DEPENDENT OR PPI TREATMENT-RESISTANT GERD). A TOTAL OF 13 PATIENTS WERE INCLUDED. AFTER 24 MONTHS ARMS, GERD SYMPTOMS WERE SIGNIFICANTLY IMPROVED FOR THE 11 REMAINING PATIENTS, FOR WHOM MEDIAN GERD-HRQL SCORE DECREASED FROM 33 (IQR 26-42) TO 3 (IQR 0-7) (P = 0:001). HEARTBURN, REGURGITATION AND DYSPHAGIA HAD DISAPPEARED FOR ALL THE PATIENTS AT 24 MONTHS. DESPITE THESE SHORT-TERM ADVERSE EVENTS, THE OVERALL PATIENT SATISFACTION IN REDUCING GERD SYMPTOMS WAS VERY GOOD, 9/11 PATIENTS (81%) WERE WILLING TO REPEAT ARMS IF NEEDED. IN THIS PILOT STUDY, ARMS OF ESOPHAGOGASTRIC JUNCTION (EGJ) WAS A FEASIBLE AND EFFECTIVE MEDIUM-TERM TECHNIQUE FOR GERD TREATMENT WITH A RELATIVELY HIGH MORBIDITY RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE BLEEDING - 13 PATIENTS. 13 PATIENTS HAD INTRAOPERATIVE BLEEDING AND THE FOLLOWING COMPLICATIONS, RESPECTIVELY. MELENA - 1 PATIENT. MELENA & PAIN - 1 PATIENT. IMMEDIATE OR POSTOPERATIVE THORACIC OR ABDOMINAL PAIN - 7 PATIENTS. INTERMITTENT PAIN - 1 PATIENT. EGJ STENOSIS - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (FD-410LR). (B)(6)(GIF-HQ190). 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
    1877420 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R