BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 14595245 · Received June 3, 2022

    Report

    Report Number
    8010047-2022-09394
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    June 28, 2021
    Report Date
    July 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    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 HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON 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. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D8, 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

    IT IS REPORTED IN THE LITERATURE ARTICLE TITLED:¿ LONG-TERM OUTCOMES OF ENDOSCOPIC BALLOON DILATION FOR INTESTINAL STRICTURES IN PATIENTS WITH CROHN¿S DISEASE DURING MAINTENANCE TREATMENT WITH ANTI-TUMOR NECROSIS FACTOR ALPHA ANTIBODIES,¿ PATIENT EXPERIENCED ADVERSE EVENTS DURING AND AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-P240AI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AI. STUDY BACKGROUND AND AIM: EFFICACY OF ENDOSCOPIC BALLOON DILATION (EBD) FOR INTESTINAL STRICTURES IN PATIENTS WITH CROHN¿S DISEASE (CD) RECEIVING ANTI-TUMOR NECROSIS FACTOR ALPHA ANTI BODIES (ANTI-TNF) AS MAINTENANCE THERAPY IS UNCLEAR. WE INVESTIGATED THE LONG-TERM EFFICACY AND SAFETY OF EBD FOR INTESTINAL STRICTURES IN PATIENTS WITH CD RECEIVING ANTI-TNF. METHODS: RETROSPECTIVE DATA ANALYSIS FROM PATIENTS WITH CD WHO RECEIVED ANTI-TNF AS MAINTENANCE THERAPY FROM 2008 TO 2017, UNDERWENT EBD, AND WERE FOLLOWED UP FOR =6 MONTHS. THE PRIMARY ENDPOINT WAS THE CUMULATIVE SURGERY-FREE RATE. THE MAIN SECONDARY ENDPOINTS WERE TECHNICAL SUCCESS, REPEAT EBD RATE, RISK FACTORS AFFECTING SURGICAL OUTCOMES, AND SAFETY. RESULTS: SEVENTY-TWO PATIENTS WITH CD WERE ASSESSED. THE MEDIAN OBSERVATION PERIOD AFTER EBD WAS 50 MONTHS. THE TECHNICAL SUCCESS RATE WAS 67%. THE 3- AND 5-YEAR CUMULATIVE SURGERY-FREE RATES WERE 81.1% AND 73.5%, RESPECTIVELY. THE REPEAT EBD RATE WAS 74%. MULTIVARIABLE ANALYSES SHOWED THAT RISK FACTORS AFFECTING SURGICAL OUTCOMES WERE AGE AT DISEASE ONSET =16 YEARS (HAZARD RATIO 3.69; 95% CONFIDENCE INTERVAL 1.36¿10.01; P = 0.011). SERIOUS COMPLICATIONS REQUIRING SURGERY DEVELOPED IN THREE PATIENTS. CONCLUSIONS: ENDOSCOPIC BALLOON DILATION WAS AN EFFECTIVE AND SAFE SHORT-TERM TREATMENT AND A USEFUL LONG-TERM TREATMENT FOR CD PATIENTS WITH INTESTINAL STRICTURES RECEIVING ANTI-TNF AS MAINTENANCE THERAPY. THE ONLY SERIOUS COMPLICATION OBSERVED WAS PERFORATION IN THREE PATIENTS; HOWEVER, THEY UNDERWENT SURGERY AND RECOVERED. PERFORATION WAS OBSERVED IN 3/72 (4.2%) PATIENTS AND IN 3/290 (1.0%) ENDOSCOPIC PROCEDURES. PERFORATION DURING EBD OCCURRED ONLY IN ONE PATIENT. PERFORATION DURING INSERTION OCCURRED IN TWO PATIENTS, BOTH OF WHICH WERE IN THE AFFECTED REGION OF THE ILEUM WITH A LONGITUDINAL ULCER. BLEEDING REQUIRING TRANSFUSION OR SERIOUS COMPLICATIONS REQUIRING LONG-TERM HOSPITALIZATION WERE NOT NOTED. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801578 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-Q260AI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R