BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14845052 · Received June 28, 2022

    Report

    Report Number
    8010047-2022-10956
    Event Type
    Injury
    Date Received
    June 28, 2022
    Report Date
    July 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    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 CAN BE FOUND AT: HTTPS://DOI.ORG/10.11280/GEE.63.2508. 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. DECEMBER 2021 (SPECIFIC DATE UNKNOWN) THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED "STUDY OF 109 CASES BY ENDOSCOPIC TREATMENT (ANTI-REFLUX MUCOSECTOMY: ARMS) FOR ACID SECRETION INHIBITOR (PPI) RESISTANT REFRACTORY GASTROESOPHAGEAL REFLUX DISEASE GERD) (WITH VIDEO) ", THREE PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER AN ENDO-REFLUX MUCOSECTOMY (ARMS) USING A DISPOSABLE ELECTROSURGICAL SNARE. STUDY AIM: INVESTIGATE THE EFFICACY OF ARMS IN PATIENTS WITH PPI REFRACTORY GERD. METHOD: RETROSPECTIVE REVIEW OF 109 PATIENTS WITH PPI REFRACTORY GERD WHO UNDERWENT ARMS AND COMPARED THE QUESTIONNAIRE SCORES, ACID-EXPOSURE TIMES, NUMBER OF DEMEESTER SCORE, PROXIMAL REFLUX, AND PPI DISCONTINUATION RATES BEFORE AND AFTER ARMS. RESULTS: SUBJECTIVE SYMPTOMS WERE SIGNIFICANTLY IMPROVED (P<0.01) AND PPI COULD BE DISCONTINUED IN 40-50% OF THE PATIENTS AFTER ARMS. IN ADDITION, IMPROVEMENT IN SUBJECTIVE SYMPTOMS WAS MAINTAINED IN THE 3-YEAR FOLLOW-UP PATIENTS. ACID-EXPOSURE TIME OR DEMEESTER SCORE IMPROVED AFTER ARMS (P<0.01), BUT PROXIMAL REFLUX DID NOT IMPROVE SIGNIFICANTLY (P=0.0846). CONCLUSION: ARMS IS A VALUABLE MINIMALLY INVASIVE TREATMENT FOR PEOPLE WITH PPI REFRACTORY GERD. THE EFFECTIVENESS OF TREATMENT IS DUE TO INHIBITION OF ACID REFLUX BY SCAR FORMATION IN THE CARDIA. TWO POSTOPERATIVE BLEEDING EVENTS OCCURRED IN PATIENTS. THESE PATIENTS WERE TREATED WITH ENDOSCOPIC HEMOSTASIS WITHOUT THE USE OF BLOOD TRANSFUSIONS. MINOR PERFORATION WAS OBSERVED IN ONE PATIENT. THIS PATIENT WAS TREATED WITH ENDOSCOPIC CLIP CLOSURE OF THE DEFECT. NO ADDITIONAL CONSEQUENCES TO THE PATIENTS WERE REPORTED. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY. [TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS] POSTOPERATIVE BLEEDING 2 CASES . SMALL PERFORATION 1 CASE . THIS ARTICLE INCLUDES 3 REPORTS: (B)(6)/SD-221L-25. (B)(6)/GIF-Q260J. (B)(6)/MAJ-296. THIS REPORT IS 2 OF 3 FOR (B)(6)/GIF-Q260J.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THERE WAS NO MALFUNCTION RELATED TO THE OLYMPUS DEVICE. THE AUTHOR STATED IT IS PRESUMED THE ADVERSE EVENTS WERE NOT CAUSED BY A DEFECT IN THE PRODUCT, BUT THE CAUSE COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909993 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKNOWN LOT: SD-221L-25, MAJ-296