BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13486768 · Received February 8, 2022

    Report

    Report Number
    8010047-2022-02614
    Event Type
    Injury
    Date Received
    February 8, 2022
    Report Date
    March 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    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. THE CASE IS NOT DUE TO DESIGN. 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. THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IN THE LITERATURE TITLED ¿FACTORS ASSOCIATED WITH BLEEDING AFTER ENDOSCOPIC VARICEAL LIGATION IN CHILDREN", FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE USING AN OLYMPUS EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE, ONE OF WHICH DIED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE THREE PATIENTS THAT EXPERIENCED EARLY RE-BLEEDING SUCCESSFULLY TREATED. (THIS REPORT) CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ONE PATIENT EXPERIENCING EARLY RE-BLEEDING THAT DEVELOPED HEMORRHAGIC SHOCK LEADING TO CARDIAC ARREST, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND DEATH. STUDY AIM: EVALUATE THE RISK FACTORS FOR EARLY RE-BLEEDING AFTER EVL IN CHILDREN AND ADOLESCENTS. STUDY METHOD: RETROSPECTIVE ANALYSIS OF CHILDREN AND ADOLESCENTS WITH PORTAL HYPERTENSION (PHT) WHO UNDERWENT EVL FOR ESOPHAGOGASTRIC VARICES. RESULTS: 50 EVL SESSIONS ON 22 PATIENTS WERE ELIGIBLE FOR THIS STUDY. EARLY RE-BLEEDING WAS DEFINED AS HEMATEMESIS, ACTIVE BLEEDING, OR BLOOD RETENTION IN THE STOMACH, THAT WAS CONFIRMED BY ESOPHAGOGASTRODUODENOSCOPY FROM 2 HOURS TO 5 DAYS AFTER EVL. FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, ONE OF WHICH DIED. CONCLUSION: CONCLUSIONS: CHILDREN AND ADOLESCENTS WHO UNDERGO EVL FOR CARDIAC VARICES JUST BELOW THE ESOPHAGOGASTRIC JUNCTION (EGJ) HAVE A HIGHER RISK OF EARLY RE-BLEEDING THAN THOSE WHO DO NOT. THIS REPORT: THREE PATIENTS THAT EXPERIENCED EARLY RE-BLEEDING WERE SUCCESSFULLY TREATED WITH ADDITIONAL EVL PROCEDURE, ENDOSCOPIC CLIPPING, OR HYPERTONIC SALINE-EPINEPHRINE INJECTION. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904815 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R