BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 8273346 · Received January 24, 2019

    Report

    Report Number
    8010047-2019-00945
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR SERRATIA MARCESCENS(>100CFU), PSEUDOMONAS AERUGINOSA(>100CFU) AND ENTEROBACTER CLOACAE(>100CFU) DURING THE ROUTINE SURVEILLANCE CULTURING TEST AT THE USER FACILITY. IT WAS ALSO REPORTED THAT THE USER FACILITY HAD BRUSHED THE SUBJECT DEVICE USING A NON-OLYMPUS CLEANING BRUSH(ABS MODEL ANI865023) AND REPROCESSED USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (SOLUSCOPE S4) WITH PERACETIC ACID. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS FRANCE (OFR). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING ROUTINE SURVEILLANCE CULTURING TESTS AT THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED BACTERIA. OTHER DETAILED INFORMATION SUCH AS TYPE AND NUMBER OF THE BACTERIA WAS NOT PROVIDED FROM THE USER FACILITY. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69506 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H185I

    Patients

    Seq Age Sex Outcome Treatment
    1