BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 11128972 · Received January 6, 2021

    Report

    Report Number
    8010047-2021-00980
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    February 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE IS A SERVICE RECORD FOR THE DEVICE. THE DEVICE WAS REPAIRED DUE TO WHITE DOTS IN THE ENDOSCOPIC IMAGE IN OCTOBER 2014. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE IS A POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO AN EXCESSIVE PHYSICAL STRESS DUE TO DEVICE HANDLING OF THE USER.

    Description of Event or Problem · 1

    THE CONNECTION PART OF THE BENDING SECTION OF THE DEVICE GOT LOOSE. THIS PHENOMENON MIGHT CAUSE THE METAL TUBE OF THE BENDING SECTION WAS EXPOSED OR DETACHED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19133 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-PQ260L

    Patients

    Seq Age Sex Outcome Treatment
    1