BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 11061569 · Received December 22, 2020

    Report

    Report Number
    8010047-2020-10832
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 27, 2020
    Report Date
    February 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305153
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER OLYMPUS MEDICAL SYSTEMS CORP. CONCLUDED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE REPROCESSING METHOD BY THE USER FACILITY. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4) (OAZ) FOR EVALUATION. IN THE EVALUATION OF OAZ THE FOLLOWING WAS CONFIRMED; OAZ COULDN'T DUPLICATE THE REPORTED PHENOMENON. THERE WERE DEFECTS IN THE LIGHT GUIDE OF THE ENDOSCOPE CONNECTOR, THE UNIVERSAL CORD, AND THE DISTAL END, AND OAZ REPLACED AND REPAIRED THEM. 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN THE USER WIPED THE OUTSIDE OF THE DEVICE AND CLEANED THE DISTAL END, THE USER FOUND A LITTLE WIRE STICKING OUT OF THE DISTAL END. AND WHEN THE USER MANUALLY REPROCESSED THE DISTAL END WITH A BRUSH TO CLEAN IT, AN OILY, GREASY FOREIGN MATERIAL EXITED FROM THE CHANNEL. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524172 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1