BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II PEDI VIDEO COLONOSCOPE

    MDR report key: 3201770 · Received June 28, 2013

    Report

    Report Number
    8010047-2013-00214
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 28, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION WITH THIS REPORT AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDED REPROCESSING TRAINING PER THE USER FACILITY'S REQUEST. DURING THE VISIT THE ESS OBSERVED THAT THE STAFF WERE PERFORMING ALL THE REPROCESSING STEPS IN ACCORDANCE WITH THE REPROCESSING MANUAL. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL NOTED THAT THE DISTAL END UNIT, BENDING SECTION, BENDING SECTION GLUE, INSERTION TUBE, AND THE BIOPSY PORT EXAMINED WITH A BOROSCOPE AND A YELLOWISH RESIDUE BUILDUP WAS NOTED. IN ADDITION, THE CHANNEL MOUNT, SUCTION CYLINDER UNIT, SUCTION MOUTHPIECE, CHANNEL PIPE AND THE AUXILIARY PORT WERE EXAMINED AND YELLOWISH BUILDUP WAS ALSO NOTED. THE RESIDUAL BUILDUP WAS ATTRIBUTED TO INSUFFICIENT CLEANING AND IMPROPER REPROCESSING. THE DEVICE WAS REFURBISHED. PLEASE CROSS-REFERENCE 8010047-2013-00186 FOR THE OTHER PT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TWO PTS WERE DIAGNOSED WITH COLITIS AFTER HAVING UNDERGONE DIAGNOSTIC COLONOSCOPIES ON THE SAME DAY. OLYMPUS OBTAINED ADDITIONAL INFO REGARDING THE REPORT OF THE EVENT. THE PT UNDERWENT A DIAGNOSTIC COLONOSCOPY DUE TO FAMILY HISTORY OF COLON CANCER. ON (B)(6) 2013, THE PT PRESENTED TO THE EMERGENCY ROOM (ER) WITH ABDOMINAL PAIN AND A FEVER OF 101 FAHRENHEIT. THE PT'S BLOOD COUNT WAS 25 AND THE CT SCAN SHOWED COLITIS AT THE SPLENTIC FLEXTURE. THE PT WAS TREATED WITH ZOFRAN AND FLAGYL IV. THE PT WAS SUPPOSE TO HAVE A FOLLOW UP APPOINTMENT TWO WEEKS POST-DISCHARGE BUT DID NOT COME IN. THE PT HAS NOT COME IN FOR ADDITIONAL VISITS AND IS REPORTEDLY DOING FINE. PER THE USER FACILITY, THE DEVICE IS USED 4-5 TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296194 OLYMPUS EVIS EXERA II PEDI VIDEO COLONOSCOPE PEDIATRIC VIDEO COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other