BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 7946205 · Received October 9, 2018

    Report

    Report Number
    8010047-2018-01939
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    August 27, 2018
    Report Date
    November 12, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    UDI-DI
    04953170237423
    PMA / PMN Number
    K071254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 (B)(4). 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 ON AUGUST 21, 2018, THE SUBJECT DEVICE TESTED POSITIVE FOR ENTEROBACTER CLOACAE (9CFU/85ML). IT WAS ALSO INFORMED THAT THE SUBJECT DEVICE TESTED REPEATEDLY POSITIVE FOR ENTEROBACTER CLOACAE DURING ADDITIONAL CULTURING TEST AT THE USER FACILITY ON AUGUST 27, 2018 AS FOLLOWS: THE INSTRUMENT CHANNEL: ENTEROBACTER CLOACAE (3CFU/50ML), THE AIR/WATER CHANNEL: ENTEROBACTER CLOACAE (36CFU/50ML). IN THE CULTURING TEST AUGUST 27, 2018, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE SUCTION CHANNEL. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (SOLUSCOPE S4) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787012 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-Q180 04953170237423

    Patients

    Seq Age Sex Outcome Treatment
    1