BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17203595 · Received June 26, 2023

    Report

    Report Number
    9610595-2023-09299
    Event Type
    Injury
    Date Received
    June 26, 2023
    Date of Event
    March 15, 2023
    Report Date
    August 1, 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
    PO
    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. IN ADDITION, THE MALFUNCTION OF THE DEVICE HAS NOT BEEN REPORTED, AND FROM CLINICAL/MEDICAL EVALUATION AND RISK ASSESSMENT, IT IS POSSIBLE THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE 4581 IS USED FOR THE SERIOUS EVENT OWING TO SUTURE OF THE ANTERIOR GASTRIC WALL TO THE ABDOMINAL WALL AND DIAPHRAGM. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE LITERATURE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC SLEEVE GASTROPLASTY: EARLY RESULTS OF A MINIMALLY INVASIVE PROCEDURE IN PATIENTS WITH OBESITY." LITERATURE SUMMARY: THIS STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) IN TERMS OF EXCESS WEIGHT LOSS (EWL) AND TOTAL WEIGHT LOSS (TWL) AT 1 AND 3 MONTHS POST-PROCEDURE AND TO COMPARE FACTORS AT BASELINE INFLUENCING POST-PROCEDURAL WEIGHT LOSS. A TOTAL OF 73 PATIENTS WERE INCLUDED AND WERE DIVIDED INTO 3 GROUPS ACCORDING TO OBESITY CATEGORY, I, II, AND III. THE MEAN DURATION OF THE ESGS WAS 83±20 MIN. AN AVERAGE OF 4.84±0.6 SUTURES WERE USED PER PROCEDURE. THERE WERE NO SIGNIFICANT DIFFERENCES IN MEAN WEIGHT REDUCTION ACROSS THE GROUPS AT 3 MONTHS. HOWEVER, THE %EWL (FIG. 6) WAS SIGNIFICANTLY DIFFERENT ACROSS OBESITY GROUPS AT 3 MONTHS FOLLOW-UP, WITH 45.9±9.8 FOR OBESITY CLASS I, 36.9 ± 10.8 FOR OBESITY CLASS II AND 29.4±8.6 FOR OBESITY CLASS III (P=0.001). ESG IS A SAFE MINIMALLY INVASIVE PROCEDURE THAT IS EFFECTIVE IN INDUCING WEIGHT LOSS IN PEOPLE WITH OBESITY. SIGNIFICANT WEIGHT LOSS AT 3 MONTHS WAS ONLY OBSERVED IN PATIENTS WITH OBESITY CLASS I AND CLASS II PATIENTS. THERE WERE A TOTAL OF 16 ADVERSE EVENTS REGISTERED (21.9%), OF WHICH 15 WERE MILD; NAUSEA AND VOMITING IN 13 (17.8%) AND ABDOMINAL PAIN IN 2 (2.7%). THESE WERE TREATED CONSERVATIVELY WITH APPROPRIATE MEDICATION, LEADING TO A MEDIAN HOSPITALIZATION OF 2.00 DAYS (RANGE 2¿17). THERE WAS ONE SERIOUS EVENT (1.4%) OWING TO SUTURE OF THE ANTERIOR GASTRIC WALL TO THE ABDOMINAL WALL AND DIAPHRAGM. THIS WAS ADDRESSED LAPAROSCOPICALLY BY CUTTING THE SUTURES AND PERFORMING PERITONEAL LAVAGE WITH DRAINAGE, AND THE PATIENT WAS DISCHARGED AFTER 15 DAYS OF HOSPITALIZATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. EVENT1: NAUSEA AND VOMITING - 13 PATIENTS. EVENT2: ABDOMINAL PAIN - 2 PATIENTS. EVENT3: SUTURE OF THE ANTERIOR GASTRIC WALL - 1 PATIENT. 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
    930529 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