BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 20669863 · Received November 12, 2024

    Report

    Report Number
    9610595-2024-40023
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    January 31, 2025
    Report Date
    February 1, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO PROVIDE A CORRECTION TO THE INITIAL MEDWATCH MEDICAL DEVICE REPORT (MDR). THE INITIAL MDR WAS ERRONEOUSLY SUBMITTED AS A REPORTABLE MALFUNCTION. THERE ARE NO REPORTABLE MALFUNCTIONS RELATED TO THE SUBJECT DEVICE CAPTURED IN THIS COMPLAINT. PER THE LEGAL MANUFACTURER, THIS DEVICE HAS NO ISSUES THAT HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THEY WERE TO RECUR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FLEX VIDEO SCOPE EXHIBITED AN ABNORMAL IMAGE. THERE WERE NO REPORTS OF PATIENT HARM. REPORTED EVENT: ABNORMAL IMAGE NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS. THE PRODUCT WAS RETURNED TO YUAN YU ON 22-OCT-2024 NO PRODUCT RETURN TO OLYMPUS. OTHER INFORMATION FROM PRODUCT COMPLAINT FORM: EVENT OCCURRED AT: PREPARATION FOR USE PURCHASE DATE: 21-SEP-2018. THE FOLLOWING MESSAGE WAS OBTAINED IN THE FILE NAMED 1133071 DISCOVERY REPORT - INQ-27736.XLSM. THE TITLE OF THE FILE IS INCOMING INSPECTION (1) RESULT [IISE]. TEST RESULTS FOR OTHER ITEMS WERE NOT CAPTURED BECAUSE THE TEST RESULTS WERE PASSED. FOR MORE DETAILS, PLEASE REFER TO THE ATTACHMENT. 1.EVENT: DUE TO DAMAGE ON SW1, WATER TIGHTNESS IS LOST. PAE CLASSIFICATION: NOT APPLICABLE UNIVERSAL FAILURE CODE: THE WATERTIGHT AREA BECOMES DEFECTIVE[GIL1103B]. 2.EVENT: DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN LEFT/RIGHT/DOWN/UP DIRECTION DOES NOT MEET THE STANDARD VALUE. PAE CLASSIFICATION: NOT APPLICABLE UNIVERSAL FAILURE CODE: THE ANGLE WIRES WERE STRETCHED[GIB1211A]. 3.EVENT: ADHESIVE AROUND LG LENS IS PEELED. PAE CLASSIFICATION: NOT APPLICABLE UNIVERSAL FAILURE CODE: OTHER FAILURE MODE[GIE2314Y]. 4.EVENT: ADHESIVE ON A-RUBBER IS DETACHED. PAE CLASSIFICATION: NOT APPLICABLE UNIVERSAL FAILURE CODE: GAP OF ADHESIVE ON A-RUBBER[GIB2111A].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976749 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H290L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown