BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 23260427 · Received October 9, 2025

    Report

    Report Number
    9610595-2025-25197
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    August 22, 2024
    Report Date
    October 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ESTABLISHMENT NAME: (B)(6) HOSPITAL. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. UPDATED FIELDS: H6, H11. 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. OLYMPUS MADE MULTIPLE ATTEMPTS 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 "A RETROSPECTIVE STUDY OF 290 PATIENTS WITH RESECTABLE BENIGN AND MALIGNANT GASTRIC NEOPLASMS TO COMPARE POSTOPERATIVE OUTCOMES OF ENDOSCOPIC RESECTION WITH AND WITHOUT THE INTERNAL TRACTION METHOD USING A SPRING-AND-LOOP WITH CLIP (S-O CLIP)." BACKGROUND: THE SPRING-AND-LOOP WITH CLIP (S-O CLIP) CONSISTS OF A SPRING AND A NYLON LOOP LOCATED ON ONE SIDE OF THE CLAWS OF THE CLIP AND IS USED IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) TO ALLOW COUNTERTRACTION. THIS RETROSPECTIVE STUDY INCLUDED 290 PATIENTS WITH EARLY GASTRIC NEOPLASMS (EGNS) AND AIMED TO COMPARE POSTOPERATIVE OUTCOMES OF ESD WITH AND WITHOUT THE USE OF THE S-O CLIP. MATERIAL/METHODS: WE RETROSPECTIVELY REVIEWED THE DATA OF 347 PATIENTS WITH EGN WHO UNDERWENT ESD, WITH OR WITHOUT AN S-O CLIP, AT OUR INSTITUTION BETWEEN (B)(6) 2017 AND (B)(6) 2023. OVERALL, 290 PATIENTS WERE ANALYZED AFTER EXCLUDING INELIGIBLE PARTICIPANTS. THE CONTROL GROUP (N=149; ADENOMA: 1, CARCINOMA: 148) UNDERWENT ESD WITHOUT AN S-O CLIP BETWEEN APRIL 2017 AND MARCH 2020, WHILE THE S-O GROUP (N=141; ADENOMA: 4, CARCINOMA: 137) USED THE CLIP BETWEEN APRIL 2020 AND MARCH 2023. PRIMARY OUTCOMES INCLUDED PROCEDURE TIME, EN BLOC RESECTION RATE, AND COMPLETE RESECTION RATE. SUBGROUP ANALYSIS FOR EXAMINED PROCEDURE TIME CONCERNING ENDOSCOPIST EXPERTISE, SUBMUCOSAL FIBROSIS, AND NEOPLASM LOCATIONS. FIBROSIS IN THE SUBMUCOSAL LAYER CAN OCCUR DUE TO VARIOUS FACTORS, INCLUDING PRE-TREATMENT BIOPSIES, PRIOR ENDOSCOPIC TREATMENTS, INFLAMMATION OF THE MUCOSA, AND SUBMUCOSAL TUMOR INVASION. IN GENERAL CASES, THE SUBMUCOSAL LAYER APPEARS TRANSLUCENT, ALLOWING THE UNDERLYING STRUCTURES TO BE VISIBLE (FIGURE 4D). HOWEVER, SEVERE FIBROSIS MANIFESTS AS A THICK, WHITE, RIDGED STRUCTURE, COMPLICATING THE VISIBILITY AND DISSECTION PROCESS IN ESD. THE PRESENCE OR ABSENCE OF FIBROSIS IN THE SUBMUCOSAL LAYER WAS DETERMINED MACROSCOPICALLY BY ENDOSCOPISTS BASED ON INTRAOPERATIVE AND POSTOPERATIVE ENDOSCOPIC IMAGES. THE PRESENCE OF FIBROSIS IN THE SUBMUCOSAL LAYER WAS SHOWN IN BOTH GROUPS (%). GASTRIC PERFORATION WAS ENDOSCOPICALLY IDENTIFIED DURING ESD. SPECIFICALLY, THIS WAS DETERMINED BY OBSERVING THE EXTERNAL TISSUE THROUGH THE GASTRIC SEROSA DURING ESD. WE ALSO REGARDED SUBDIAPHRAGMATIC INTRA-ABDOMINAL FREE GAS ON RADIOGRAPHY IN THE UPRIGHT POSITION, ROUTINELY PERFORMED ON POSTOPERATIVE DAY (POD) 1 OF ESD, AS GASTRIC PERFORATION. PATIENTS WITH DELAYED GASTRIC PERFORATION WERE ALSO INCLUDED, AND THE RATE OF GASTRIC PERFORATION (%) WAS COMPARED BETWEEN THE GROUPS. POST-ESD BLEEDING WAS DEFINED AS A BLEEDING OCCURRING POST-ESD THAT NECESSITATED ENDOSCOPIC HEMOSTASIS. THE OCCURRENCE RATE OF POST-ESD BLEEDING (%) WAS COMPARED BETWEEN THE GROUPS. RESULTS: THE S-O GROUP HAD A SHORTER PROCEDURE TIME (44.4±23.9 VS 61.1±40.9 MIN, P<0.001) AND A HIGHER COMPLETE RESECTION RATE (97.9% VS 92.6%, P<0.05) THAN THE CONTROL GROUP. SUBGROUP ANALYSIS REVEALED THAT THE S-O CLIP SIGNIFICANTLY REDUCED PROCEDURE TIME FOR TRAINEES COMPARED TO THE CONTROL GROUP (40.8±18.3 VS 61.1±35.6 MIN, P<0.05). CONCLUSIONS: THE SCHEDULED USE OF S-O CLIPS IN GASTRIC ESD IS EFFECTIVE IN IMPROVING PROCEDURAL TIME AND COMPLETE RESECTION RATES, BENEFITING ENDOSCOPISTS ACROSS ALL EXPERIENCE LEVELS. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS. GASTRIC PERFORATION (2 PATIENTS). POST-ESD BLEEDING (12 PATIENTS).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218603 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DUAL KNIFE (KD-650L, OLYMPUS)| ELECTROSURGICAL GENERATOR (VIO3, ERBE)| S-O CLIP| SNARE MASTER (SD-210U-15, OLYMPUS)| STANDARD CLIP