BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13653100 · Received March 2, 2022

    Report

    Report Number
    8010047-2022-03776
    Event Type
    Injury
    Date Received
    March 2, 2022
    Report Date
    April 15, 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. 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. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL 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 FOLLOWING ARTICLE: "DETECTION OF SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL NEOPLASIA BY CHROMOENDOSCOPY-GUIDED CONFOCAL LASER ENDOMICROSCOPY" BY JIN HUANG, YUN-SHENG YANG, ZHONG-SHENG LU, ET AL. THE SINGLE-CENTER STUDY WAS AIMED TO DETERMINE THE DIAGNOSTIC POTENTIAL OF CONFOCAL LASER ENDOMICROSCOPY (CLE) COMBINED WITH LUGOL'S IODINE CHROMOENDOSCOPY (LIC) IN DETECTING SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL NEOPLASIA (ESCN) USING A HISTOLOGICAL EXAMINATION OF EN BLOC ENDOSCOPIC RESECTION (ER) SPECIMENS AS THE STANDARD. THE LIC- CLE WAS PERFORMED IN 52 ENROLLED PATIENTS. IN THE SAME PATIENTS, A CHROMOENDOSCOPY-GUIDED BIOPSY WAS PERFORMED BY ANOTHER ENDOSCOPIST, AND THEY WERE COMPARED FOR THE DETECTION RATES. THE REPORTED SENSITIVITY, SPECIFICITY, NEGATIVE PREDICTIVE VALUE, AND POSITIVE PREDICTIVE VALUE OF CHROMOENDOSCOPY-GUIDED CLE WERE 95.7%, 90%, 81.8%, AND 97.8%, RESPECTIVELY. IN CONCLUSION, THE STUDY DEMONSTRATED THAT ESCN COULD BE DIAGNOSED RELIABLY BY LIC-CLE. A TOTAL OF 56 LESIONS IN 52 PATIENTS WERE ENROLLED FOR THE STUDY, INCLUDING 16 FEMALES AND 36 MALES (MEAN AGE, 60.5 YEARS; RANGE, 43-78 YEARS). THE AUTHORS USED MULTIPLE OLYMPUS DEVICES AND DID NOT SPECIFY THE DEVICES USED IN RELATION TO THE ADVERSE EVENTS EXPERIENCED. THEREFORE ALL OLYMPUS DEVICES WILL BE REPORTED. THE ADVERSE EVENTS REPORTED: ENDOSCOPIC HEMOSTASIS WAS PERFORMED EITHER WITH THE KNIFE OR HEMOSTATIC FORCEPS (FD-410LR; OLYMPUS OPTICAL CO., LTD., TOKYO, JAPAN) WHENEVER BLEEDING WAS NOTED. AFTER DISSECTION, PREVENTIVE ENDOSCOPIC HEMOSTASIS WAS PERFORMED FOR ANY OOZING OR EXPOSED VESSEL. MINOR BLEEDING WAS ENCOUNTERED IN ALL ER PROCEDURES, BUT SUCCESSFUL HEMOSTASIS WAS ALWAYS ACHIEVED USING THERMOCOAGULATION. NO PATIENT EXPERIENCED MASSIVE HEMORRHAGE REQUIRING A BLOOD TRANSFUSION OR POSTPROCEDURAL EMERGENT ENDOSCOPY. NO DELAYED HEMORRHAGE OCCURRED. EXPOSURE OF THE MUSCULAR LAYER DURING ESD OCCURRED IN FOUR CASES, BUT NO OVERT ESOPHAGEAL PERFORATION. TREATMENT NOT SPECIFIED. THERE ARE 6 REPORTS FOR THIS ARTICLE: PATIENT IDENTIFIER (B)(6) IS FOR KD-610L. PATIENT IDENTIFIER (B)(6) IS FOR KD-1L. PATIENT IDENTIFIER (B)(6) IS FOR FD-410LR. PATIENT IDENTIFIER (B)(6) IS FOR GIF-H260. PATIENT IDENTIFIER (B)(6) IS FOR CLV-260SL. PATIENT IDENTIFIER (B)(6) IS FOR GIF-Q260J. THIS IS REPORT 6 OF 6 FOR PATIENT IDENTIFIER (B)(6) IS FOR GIF-Q260J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280108 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O FD-410LR, CLV-260SL| GIF-H260, GIF-Q260J| KD-610L, KD-1L