BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 23720893 · Received December 4, 2025

    Report

    Report Number
    9610595-2025-36831
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    August 20, 2025
    Report Date
    December 4, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1:(B)(6) THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION.¿ BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED.¿ MULTIPLE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE AUTHOR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "DEVELOPMENT AND VALIDATION OF AN INTRAOPERATIVE PERFORATION PREDICTION SCORING SYSTEM FOR ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMORS." LITERATURE SUMMARY BACKGROUND: ENDOSCOPIC RESECTION (ER) IS A MINIMALLY INVASIVE TREATMENT FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GGISTS), BUT INTRAOPERATIVE PERFORATION RISK REMAINS A SIGNIFICANT CONCERN. CURRENTLY, NO VALIDATED TOOLS EXIST TO PREOPERATIVELY IDENTIFY HIGH-RISK PATIENTS. THIS STUDY AIMED TO DEVELOP AND VALIDATE A PRACTICAL SCORING SYSTEM FOR PREDICTING INTRAOPERATIVE PERFORATION DURING ER OF GGISTS. METHODS: A MULTI-CENTER RETROSPECTIVE STUDY ANALYZED 1,124 PATIENTS UNDERGOING ER FOR GGISTS, DIVIDED INTO TRAINING (N = 496), INTERNAL VALIDATION (N = 212), AND EXTERNAL VALIDATION COHORTS (N = 416). INDEPENDENT RISK FACTORS FOR INTRAOPERATIVE PERFORATION WERE IDENTIFIED THROUGH UNIVARIATE AND MULTIVARIATE LOGISTIC REGRESSION AND WEIGHTED BY REGRESSION COEFFICIENTS TO CONSTRUCT THE SCORING SYSTEM. MODEL PERFORMANCE WAS ASSESSED USING THE AREA UNDER THE CURVE (AUC), SENSITIVITY, SPECIFICITY, ACCURACY, POSITIVE PREDICTIVE VALUE (PPV), AND NEGATIVE PREDICTIVE VALUE (NPV). DEFINITIONS INTRAOPERATIVE PERFORATION IS DEFINED AS AN UNINTENTIONAL BREACH OF THE GASTRIC SEROSAL LAYER THAT OCCURS DURING ER, THEREBY ESTABLISHING A COMMUNICATION PATHWAY BETWEEN THE GASTRIC CAVITY AND THE ABDOMINAL CAVITY (16). THIS DEFINITION EXCLUDES ANY PLANNED FULL-THICKNESS RESECTIONS THAT ARE INTENTIONALLY PERFORMED AS PART OF THE SURGICAL STRATEGY. THE ASSESSMENT OF TUMOR CHARACTERISTICS, ENCOMPASSING LOCATION, SHAPE, BORDER, AND SIZE, WAS PREDOMINANTLY CONDUCTED USING PREOPERATIVE ENDOSCOPIC ULTRASONOGRAPHY (EUS). THE DIAGNOSIS OF POSTOPERATIVE PERFORATION WAS ESTABLISHED IF NO PERFORATION WAS DETECTED DURING THE SURGICAL PROCEDURE OR IMMEDIATELY THEREAFTER AND WAS SUBSEQUENTLY FOLLOWED BY THE DELAYED MANIFESTATION OF SIGNS INDICATIVE OF PERITONEAL IRRITATION OR RADIOGRAPHIC EVIDENCE OF FREE AIR BENEATH THE DIAPHRAGM, AS OBSERVED ON POSTOPERATIVE ABDOMINAL PLAIN FILM OR COMPUTED TOMOGRAPHY (CT) (19). POSTOPERATIVE HEMORRHAGE IS CHARACTERIZED BY THE ONSET OF SIGNIFICANT HEMATEMESIS OR MELENA FOLLOWING ENDOSCOPIC INTERVENTION, ACCOMPANIED BY A DECLINE IN HEMOGLOBIN LEVELS OF 2 G/DL OR GREATER, ALTERATIONS IN VITAL SIGNS, AND VERIFICATION OF MUCOSAL DEFECT BLEEDING OR GASTRIC HEMORRHAGE VIA EMERGENCY ENDOSCOPY (20). RESULTS: INTRAOPERATIVE PERFORATION OCCURRED IN 463 PATIENTS (41.2%). THREE INDEPENDENT PREDICTORS WERE IDENTIFIED: TUMOR LOCATION (GASTRIC FUNDUS, 2 POINTS), SIZE (= 2.0 CM, 2 POINTS), AND GROWTH PATTERN (INTRALUMINAL-DOMINANT, 1 POINT; EXTRALUMINAL DOMINANT, 3 POINTS). THE SCORING SYSTEM DEMONSTRATED STRONG DISCRIMINATION, WITH AUCS OF 0.805 (INTERNAL VALIDATION) AND 0.811 (EXTERNAL VALIDATION). ACCURACY WAS 0.726 AND 0.805, RESPECTIVELY. RISK STRATIFICATION REVEALED INTRAOPERATIVE PERFORATION RATES OF 8.3% (LOW-RISK: 0-1 POINTS), 38.5% (INTERMEDIATE-RISK: 2-3 POINTS), AND 80.0% (HIGH-RISK: 4-7 POINTS) IN THE INTERNAL VALIDATION COHORT, AND 4.8%, 36.6%, AND 85.5% IN THE EXTERNAL VALIDATION COHORT. AMONG THE 27 PATIENTS WHO ENCOUNTERED POSTOPERATIVE BLEEDING, 26 PATIENTS ATTAINED SUCCESSFUL HEMOSTASIS VIA ENDOSCOPIC ELECTROCOAGULATION OR TITANIUM CLIP LIGATION. ONE PATIENT NECESSITATED CONVERSION TO OPEN SURGERY OWING TO SEVERE HEMORRHAGE. THE SINGLE PATIENT WHO DEVELOPED POSTOPERATIVE PERFORATION EXHIBITED CLINICAL IMPROVEMENT FOLLOWING A COMPREHENSIVE TREATMENT REGIMEN ENCOMPASSING GASTROINTESTINAL DECOMPRESSION, ANTI-INFLAMMATORY MEDICATION, FLUID REPLACEMENT, AND NUTRITIONAL SUPPORT. POSTOPERATIVE ANTIBIOTICS (SECOND-GENERATION CEPHALOSPORIN, EXAMPLE, CEFUROXIME 750 MG INTRAVENOUSLY EVERY 8 HOURS) WERE ADMINISTERED FOR 48 TO 72 HOURS IN PATIENTS WITH INTRAOPERATIVE PERFORATION OR PROCEDURE DURATION GREATER THAN 60 MINUTES. CONCLUSION: THIS NOVEL SCORING SYSTEM, INCORPORATING TUMOR LOCATION, SIZE, AND GROWTH PATTERN, RELIABLY STRATIFIES INTRAOPERATIVE PERFORATION RISK PRIOR TO ER FOR GGISTS. IT OFFERS CLINICIANS A PRACTICAL TOOL TO OPTIMIZE PATIENT SELECTION AND PROCEDURAL PLANNING, POTENTIALLY IMPROVING SAFETY OUTCOMES. FURTHER PROSPECTIVE STUDIES ARE WARRANTED TO VALIDATE ITS CLINICAL UTILITY. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS INTRAOPERATIVE PERFORATION (463 PATIENTS) DELAYED BLEEDING (27 PATIENTS) DELAYED PERFORATION (1 PATIENT) THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454502 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ERBE VIO 200D ELECTROSURGICAL UNIT| OLYMPUS KD-611L INSULATED-TIP KNIFE| OLYMPUS KD-650L DUAL KNIFE| VEDKANG KUNPENG KNIFE