BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 2040187 · Received March 24, 2011

    Report

    Report Number
    8010047-2011-00057
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 2, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDF
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE WAS USED ON BOTH PTS ON THE SAME DAY. THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND SLIGHT DEBRIS AND RESIDUE INSIDE THE INSTRUMENT CHANNEL, THE AUXILIARY WATER CHANNEL, THE SUCTION CHANNEL, AND IN THE CYLINDER UNIT. THERE WERE NO AREAS ON THE ENDOSCOPE THAT WERE IDENTIFIED AS BEING SHARP, AND THE UNIT PASSED LEAKAGE TESTING. THE REPORTED PHENOMENON WAS ATTRIBUTED TO INSUFFICIENT CLEANING AND/OR IMPROPER REPROCESSING. THE DEVICE HAS BEEN RETURNED TO THE USER FACILITY. AN OLYMPUS ENDOSCOPE SERVICE SPECIALIST HAS BEEN DISPATCHED TO THE FACILITY TO FOLLOW-UP ON THIS MATTER, AND TO OFFER TRAINING AND EDUCATIONAL MATERIALS ON APPROPRIATE REPROCESSING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    OCA UNDERTOOK A RETROSPECTIVE REVIEW OF ITS MDR FILES FOR THE PERIOD OF JANUARY 2005 TO APRIL 2015. BASED UPON THIS REVIEW, WE ARE SUBMITTING THIS MDR TO SEPARATELY ACCOUNT FOR EACH OF THE THREE PATIENTS INVOLVED IN THIS EVENT.PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 8010047-2011-00110 AND 2951238-2016-00150 TO ACCOUNT FOR THE THREE PATIENTS AS REFERENCED IN THE ORIGINAL REPORT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TWO PTS COMPLAINED OF EXPERIENCING ABDOMINAL PAIN FOLLOWING A PROCEDURE IN WHICH THE SUBJECT DEVICE WAS USED. ONE OF THE TWO PTS REPORTEDLY VISITED THE EMERGENCY ROOM AND REQUIRED A CAT SCAN EXAMINATION. THERE WAS NO ADDITIONAL INFO PROVIDED REGARDING THE STATUS OF THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEM CORPORATION CF-Q160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention