BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 16714122 · Received April 11, 2023

    Report

    Report Number
    9610595-2023-05933
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 9, 2023
    Report Date
    July 5, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305238
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE FOREIGN MATERIAL WAS INSUFFICIENT CLEANING. IDENTIFICATION OF THE MATERIAL COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER SUSPECTED DEVICE WAS RETURNED FOR INVESTIGATION. THE OLYMPUS SERVICE CENTER CONFIRMED THE REPORTED EVENT DURING INSPECTION AND TESTING. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING DEFECTS WERE FOUND, DISTAL END COVER BROKE, ROOF INSULATION, PROTECTIVE RUBBER GLUE DETACHED/DISCOLORED, OBJECTIVE LENS (LINED, CHIPPED, BROKEN/FISSURED WITH AFFECTION IN IMAGE), LIGHT TRANSMISSION FIBER (15-20 % M OK > 30%), IMAGE EVIS EXERA (SMUDGE ON IMAGE), INSERTION TUBE (PHYSICAL DETERIORATION), INSERTION TUBE INSULATION (T/I, 10M OK > 10M), ANGULATIONS (ANGULATIONS OUTSIDE THE RANGE ALLOWED BY THE MANUFACTURER), CONTROL KNOBS (PLAY), AND GUAYAS OF THE ANGULATION SECTION (BROKEN, LOOSE STOPPER, FLAYED, CUT). THE FAULTY PARTS WILL BE REPLACED, AND THE DEVICE WILL BE RETURNED TO THE USER FACILITY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III COLONOVIDEOSCOPE EXHIBITED AFFECTS IMAGE DUE TO SCRATCHED AND CRACKED OBJECTIVE LENS, REDUCTION OF LIGHT FIBERS BY 15-20%, AND PHYSICAL DETERIORATION OF INSERTION TUBE. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO AN UNKNOWN DIAGNOSTIC PROCEDURE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIAL (SECRETION RESIDUES FROM MUCOUS TISSUE) WAS FOUND ON THE SCOPE DISTAL END. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623269 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-PH190L 04953170305238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown