BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14602579 · Received June 6, 2022

    Report

    Report Number
    8010047-2022-09476
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    February 10, 2022
    Report Date
    July 8, 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 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 AND FROM THE AUTHOR. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: B3, B5, H6, H10. 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 LITERATURE TITLED "RISK FACTORS FOR LYMPH NODE METASTASIS AND INDICATION OF LOCAL RESECTION IN DUODENAL NEUROENDOCRINE TUMORS". THE PRESENT STUDY AIMED TO INVESTIGATE THE CLINICOPATHOLOGICAL FEATURES OF DUODENAL NEUROENDOCRINE TUMORS (DNETS) WITH A RELATIVELY LARGE NUMBER OF CASES AND IDENTIFY THE RISK FACTORS FOR LYMPH NODE METASTASIS (LNM). IN ADDITION, SHORT- AND LONG-TERM OUTCOMES OF ENDOSCOPIC RESECTION (ER) AND LAPAROSCOPY AND ENDOSCOPY COOPERATIVE SURGERY (LECS) WERE COMPARED TO ESTABLISH THE APPLICATION OF LOCAL RESECTION FOR DNETS. 55 PATIENTS WITH 60 DNETS WERE ENROLLED; DNETS <5 MM WERE TREATED WITH ER AND THOSE OF 5¿10 MM WERE TREATED WITH LECS. LNM WAS PRESENT IN FOUR (8.7%) PATIENTS. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN TERMS OF COMPLICATION RATES. NO RECURRENCE WAS OBSERVED IN ANY OF THE GROUPS. YPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [ENDOSCOPIC RESECTION GROUP (N=18)]. INTRAOPERATIVE PERFORATION- 2 PATIENTS. [LECS GROUP (N=9)]. ABDOMINAL ABSCESS- 1 PATIENT. THE AUTHORS USED 3 OLYMPUS DEVICES AND DID NOT SPECIFY WHICH DEVICE WAS INVOLVED WITH THE ADVERSE EVENTS PATIENT IDENTIFIER (B)(6): GIF-Q260J. PATIENT IDENTIFIER (B)(6): KD-611L. PATIENT IDENTIFIER (B)(6): KD-650L. THIS REPORT IS 1 OF 3 FOR PATIENT IDENTIFIER (B)(6): GIF-Q260J.

    Description of Event or Problem · 0

    IN THE OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160601 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R LOT UNK: KD-611L OR KD-650L.| SERIAL UNK: ESG-100.