BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 14828463 · Received June 27, 2022

    Report

    Report Number
    8010047-2022-10831
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    April 11, 2017
    Report Date
    August 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    UDI-DI
    04953170339943
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO MALFUNCTIONS WERE REPORTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARISON OF THE EFFICACY AND SAFETY OF SINGLE- VERSUS DOUBLE-BALLOON ENTEROSCOPY PERFORMED BY ENDOSCOPIST EXPERTS IN SINGLE-BALLOON ENTEROSCOPY: A SINGLE-CENTER EXPERIENCE AND META-ANALYSIS". LITERATURE SUMMARY: THIS STUDY AIMED TO COMPARE THE DIAGNOSTIC YIELD, THERAPEUTIC YIELD, AND COMPLICATION RATE OF SBE VERSUS DBE PERFORMED BY A SINGLE ENDOSCOPIST WITH MORE EXPERTISE IN SBE THAN DBE. A TOTAL OF 65 PROCEDURES IN 44 PATIENTS WITH SBE AND 74 PROCEDURES IN 69 PATIENTS WITH DBE WERE ANALYZED. THERE WERE NO SIGNIFICANT DIFFERENCES IN DIAGNOSTIC YIELD (61.1% VS 77.3%, RESPECTIVELY, P=0.397), THERAPEUTIC YIELD (39.1% VS 31.8%, RESPECTIVELY, P=0.548), AND COMPLICATION RATE (4.4% VS 2.3%, P=1.000). IN THE META-ANALYSIS, WHICH INCLUDED FOUR RANDOMIZED CONTROLLED TRIALS AND THREE OBSERVATIONAL STUDIES, THERE WERE NO SIGNIFICANT DIFFERENCES IN THE POOLED RELATIVE RISK AND ODDS RATIO FOR DIAGNOSTIC AND THERAPEUTIC YIELD AND COMPLICATIONS OF SBE COMPARED WITH THOSE OF DBE. THE PERFORMANCE OF SBE APPEARS TO BE SIMILAR TO THAT OF DBE IN TERMS OF DIAGNOSTIC AND THERAPEUTIC YIELD AND COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DBE GROUP/NON-OLYMPUS DEVICE. POSTPROCEDURE ELEVATED AMYLASE - 2 PATIENTS. SBE GROUP/OLYMPUS DEVICE: POSTPROCEDURE ELEVATED AMYLASE - 1 PATIENT. PERFORATION - 1 PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS REPORTED IN THE STUDY. THE SERIAL NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071256 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-Q180 04953170339943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other