BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14160447 · Received April 20, 2022

    Report

    Report Number
    8010047-2022-06680
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    September 2, 2021
    Report Date
    June 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 A LITERATURE TITLED "THE VALUE OF ENDOSCOPIC ULTRASONOGRAPHY IN THE ENDOSCOPIC RESECTION OF GASTROINTESTINAL STROMAL TUMORS". THIS RETROSPECTIVE, SINGLE-CENTER STUDY WAS AIMED TO EXPLORE THE CLINICAL VALUE OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) IN THE ENDOSCOPIC RESECTION OF GASTROINTESTINAL STROMAL TUMORS (GISTS). A TOTAL OF 92 PATIENTS WERE INCLUDED WERE UNDERWENT ENDOSCOPIC TREATMENT, OF WHICH 89 (96.7%) PATIENTS UNDERWENT COMPLETE PATHOLOGICAL RESECTION. OF THESE 92 PATIENTS, 37 (40.2%) UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), 27 (29.4%) UNDERWENT ENDOSCOPIC SUBMUCOSAL EXCAVATION (ESE), 15 (16.3%) UNDERWENT ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR), NINE (9.8%) UNDERWENT ENDOSCOPIC BAND LIGATION (EBL), AND FOUR (4.3%) UNDERWENT SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER). THE STUDY REPORTED A 78.7% RATE FOR PREOPERATIVE DIAGNOSIS RATE OF EUS AND POSTOPERATIVE PATHOLOGICAL DIAGNOSIS OF GISTS. THE PRESENCE OF A NON-HOMOGENEOUS ECHO AND LIQUID ANECHOIC ZONE IN GISTS OFTEN INDICATED HIGHER RISK (P < 0.05). THE STUDY CONCLUDED THAT ENDOSCOPIC RESECTION OF GISTS IS FEASIBLE AND SAFE. EUS IS OF GREAT SIGNIFICANCE FOR THE DIAGNOSIS AND RISK ASSESSMENT OF GISTS AND CAN ASSIST IN THE ENDOSCOPIC RESECTION OF GISTS. THE AUTHORS USED 5 OLYMPUS DEVICES: DUAL-KNIFE (KD-655L OR KD-655Q), IT-KNIFE (KD-612L), HYALINE CAP (D-201-11804), AND GIF-Q260J AND REPORTED THE FOLLOWING: COMPLICATIONS: INTRAOPERATIVE BLEEDING OCCURRED IN TWO PATIENTS (2.2%), AND BOTH OF THESE CASES OCCURRED DURING ESE. THERMAL BIOPSY FORCEPS AND TITANIUM CLAMPS WERE SUCCESSFULLY USED TO STOP THE BLEEDING. PERFORATION OCCURRED IN 13 PATIENTS (14.1%; CASES OF PERFORATION DURING EFTR WERE NOT INCLUDED), THREE OF WHICH OCCURRED DURING EBL, SIX DURING ESD, AND FOUR DURING ESE. THESE PERFORATIONS WERE SUCCESSFULLY CLOSED WITH TITANIUM CLIPS, TITANIUM CLIPS COMBINED WITH A PURSE-STRING SUTURE, OR OTSCS®. AFTER THE PROCEDURE, ELECTROCOAGULATION SYNDROME OCCURRED IN SEVEN PATIENTS (TWO CASES AFTER ESD, TWO AFTER ESE, AND THREE AFTER EFTR). ALL THE PATIENTS IMPROVED AFTER CONSERVATIVE TREATMENTS, SUCH AS THE DEPRIVATION OF FOOD AND WATER, REHYDRATION, OR RATIONAL INTRAVENOUS USE OF ANTIBIOTICS. POSTOPERATIVE PERFORATION OCCURRED IN ONE PATIENT UNDERGOING ESD, AND THE PATIENT IMPROVED AFTER SURGERY. THE PHYSICIAN'S MEDICAL OPINION UPON FOLLOW UP STATED NO ADVERSE EVENTS WERE LINKED TO THE OLYMPUS DEVICES. THIS ARTICLE INCLUDES 4 REPORTS: (B)(6): KD-612L. (B)(6): KD-655L OR KD-655Q. (B)(6): D-201-11804. (B)(6): GIF-Q260J. THIS REPORT IS 4 OF 4 FOR (B)(6): GIF-Q260J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719502 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R UNKNOWN LOT NUMBERS: KD-612L,KD-655L.| UNKNOWN LOT NUMBERS: KD-655Q,D-201-11804.