BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16483229 · Received March 3, 2023

    Report

    Report Number
    9610595-2023-03734
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 27, 2023
    Report Date
    April 26, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170339745
    PMA / PMN Number
    K051645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE REFERENCED 2 OLYMPUS MODEL NUMBER. SINCE THE LITERATURE DESCRIBED A "DOUBLE-CHANNEL THERAPEUTIC ENDOSCOPE, GIF 2HT180 OR GIF 2HT160", OLYMPUS SELECTED MODEL NUMBER "GIF 2HT180" AS A REPRESENTATIVE PRODUCT WITH THE SAME PRODUCT NAME. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. 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. 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

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "LONG-TERM OUTCOMES OF TRANSORAL OUTLET REDUCTION (TORE) FOR DUMPING SYNDROME AND WEIGHT REGAIN AFTER ROUX-EN-Y GASTRIC BYPASS." BACKGROUND: BOTH WEIGHT REGAIN AND DUMPING SYNDROME (DS) AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) HAVE BEEN RELATED TO THE DILATION OF GASTRO-JEJUNAL ANASTOMOSIS. THE AIM OF THIS STUDY IS TO ASSESS THE SAFETY AND LONG-TERM EFFICACY OF ENDOSCOPIC TRANSORAL OUTLET REDUCTION (TORE) FOR DS AND/OR WEIGHT REGAIN AFTER RYBG. MATERIALS AND METHODS: A RETROSPECTIVE ANALYSIS WAS PERFORMED ON A PROSPECTIVE DATABASE. SIGSTAD¿S SCORE, EARLY AND LATE ARTS DUMPING SCORE (ADS) QUESTIONNAIRES, ABSOLUTE WEIGHT LOSS (AWL), PERCENTAGE OF TOTAL BODY WEIGHT LOSS (%TBWL), AND PERCENTAGE OF EXCESS WEIGHT LOSS (%EWL) WERE ASSESSED AT BASELINE AND AT 6, 12, AND 24 MONTHS AFTER TORE. RESULTS: EIGHTY-SEVEN PATIENTS (MEDIAN AGE 46 YEARS, 79% FEMALE) UNDERWENT TORE. THE MEDIAN BASELINE BMI WAS 36.2 KG/M2. OUT OF 87 PATIENTS, 58 WERE CLASSIFIED AS ¿DUMPERS¿ DUE TO SIGSTAD¿S SCORE = 7. THE RESOLUTION RATE OF DS (SIGSTAD¿S SCORE < 7) WAS 68.9%, 66.7%, AND 57.2% AT 6, 12, AND 24 MONTHS AFTER TORE, RESPECTIVELY. A SIGNIFICANT DECREASE IN SIGSTAD¿S SCORE AS WELL AS IN EARLY AND LATE ADS QUESTIONNAIRES WAS OBSERVED (P < 0.001). THE MEDIAN SIGSTAD¿S SCORE DROPPED FROM 15 (11¿8.5) PRE-OPERATIVELY TO 2 (0¿12) AT 24 MONTHS. THE %TBWL WAS 10.5%, 9.9%, AND 8.1% AT 6, 12, AND 24 MONTHS, RESPECTIVELY. FURTHER, ¿DUMPERS¿ WITH RESOLUTION OF DS SHOWED BETTER WEIGHT LOSS RESULTS COMPARED WITH THOSE WITH PERSISTENT DS (P < 0.001). THE ONLY ADVERSE EVENT OBSERVED WAS A PERIGASTRIC FLUID COLLECTION SUCCESSFULLY MANAGED CONSERVATIVELY. CONCLUSION: TORE IS A MINIMALLY INVASIVE TREATMENT FOR DS AND/OR WEIGHT REGAIN AFTER RYGB, WITH EVIDENCE OF LONG-TERM EFFICACY. TYPES OF ADVERSE EVENT(S)/ NUMBER OF PATIENTS: PERIGASTRIC COLLECTION/ N=1. 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
    503307 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-2TH180 04953170339745

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R