BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8309511 · Received February 6, 2019

    Report

    Report Number
    8010047-2019-01026
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Report Date
    March 9, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT "DEVICE PRODUCT CODE" OF D2 AND TO PROVIDE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS PARTIALLY DISASSEMBLE AND REACHED THE OLYMPUS EUROPE HOLDING (OEH). OEH INVESTIGATED THE SUBJECT DEVICE AND FOLLOWINGS WERE OBSERVED. THE INSTRUMENT CHANNEL WAS LEAKY AND WAS BADLY SCRATCHED THROUGHOUT ITS LENGTH. REMOTE SWITCH 1 WAS BROKEN. THE DISTAL END PARTS WAS DAMAGED. THERE WAS MOIST SIGN INSIDE THE LIGHT GUIDE LENS. THE ANGULATION SYSTEM WOULD BE DETERIORATED WITH TIME. OEH COULD NOT PERFORM AN ADDITIONAL MICROBIOLOGICAL TESTING DUE TO THE DEVICE CONDITION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT WAS RETURNED TO OLYMPUS EUROPA HOLDING (OEH). OEH CONFIRMED THAT THE SUBJECT DEVICE HAVE BEEN RETURNED TO OEH FOR MICROBIAL CONTAMINATION THREE TIMES (FOR MORE INFORMATION, REFER TO THE MDRS OF 8010047-2017-01460, 8010047-2018-00064, AND 8010047-2018-00833). THE SERVICE DEPARTMENT OF THE OEH FOUND AIR LEAK IN THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. AS PART OF THE OEH INVESTIGATION, OEH CHECKED REPROCESSING PRACTICE OF THE USER FACILITY AND FOUND TWO DEVIATIONS AS FOLLOWS. CLEANING BRUSH FOR THE INSTRUMENT CHANNEL WAS NOT REUSABLE, BUT WAS NOT DISPOSED AFTER USE. THE SUBJECT DEVICE WAS NOT STORED ACCORDING TO THE INSTRUCTIONS OF THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA (90 CFU / ML) AND CHRYSEOBACTERIUM INDOLOGENES (340 CFU / ML). THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE USA) USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103347 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1