BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8192634 · Received December 21, 2018

    Report

    Report Number
    2951238-2018-00805
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 12, 2018
    Report Date
    May 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FEB TO FDT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS ON THE PHYSICAL EVALUATION OF THE SCOPE AND THE RESULTS OF THE REPROCESSING TECHNIQUE REVIEW. THE ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY AND OBSERVED THE REPROCESSING PRACTICE OF THE TECHNICIAN WHO REPROCESSED THE SCOPE. THE ESS OBSERVED THE TECHNICIAN WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING. IN ADDITION, THE USER WAS UTILIZING ANOTHER MANUFACTURE'S CHANNEL CLEANING/OPENING CLEANING BRUSHES. THE TECHNICIAN WAS NOT PROPERLY BRUSHING THE DISTAL END AROUND THE ELEVATOR WITH THE MAJ-1534 FOR THE TJF-160VF SCOPE. THE TECHNICIAN WAS NOT FLUSHING PROPERLY AROUND THE ELEVATOR WITH A SYRINGE WITH DETERGENT AND RINSE WATER. IN ADDITION, THE ESS CONDUCTED A REPROCESSING IN-SERVICE TRAINING WITH GI STAFF. IN-SERVICE INCLUDED ALL CLEANING, DISINFECTION AND STERILIZATION INFORMATION CONTAINED WITH-IN THE INSTRUCTIONS FOR USE (IFU) MANUAL. THE SUBJECT SCOPE WAS SENT FOR DESTRUCTIVE SAMPLING. THE RESULTS OF THE DESTRUCTIVE SAMPLING HAVE NOT BEEN FINALIZED. THE SCOPE WAS THEN SENT TO AN INDEPENDENT LABORATORY FOR ETHYLENE OXIDE (ETO) STERILIZATION AND THEN RETURNED TO THE SERVICE CENTER FOR A PHYSICAL EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED DEVICE AND FOUND AN EXCESSIVE AMOUNT OF FOREIGN ORANGE SUBSTANCE THROUGHOUT THE SCOPE¿S INSTRUMENT AND SUCTION CHANNELS. THERE WAS NO SIGN OF FOREIGN SUBSTANCE/MATERIALS FOUND WITH THE INSERTION TUBE, BENDING SECTION COVER, BENDING SECTION COVER GLUE, LIGHT GUIDE LENS/GLUE, AND OBJECTIVE LENS/GLUE. A LEAK TEST COULD NOT BE PERFORMED; THE SCOPE WAS RECEIVED WITHOUT THE ELEVATOR FORCEPS AND DISTAL END COVER AS IT WAS DISASSEMBLED DURING THE DESTRUCTIVE SAMPLING. THE CAUSE OF THE ORANGE STAINS AND THE REPORTED POSITIVE CULTURE CANNOT BE DETERMINED AT THIS TIME AS THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AS PART OF THE PMS STUDY PROCESS, OLYMPUS PERSONNEL CONDUCTED A REVIEW OF THE SAMPLING TECHNIQUE OF THE SCOPE SAMPLER AND THERE WERE NO DEVIATIONS WERE OBSERVED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUMMARY OF THE ROOT CAUSE ANALYSIS REPORT FOR THE POSTMARKET SURVEILLANCE WITH THE REFERENCED TJF STUDY. THERE WERE NO DEVIATIONS OBSERVED DURING THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) MACHINE (CUSTOMER UTILIZED MEDIVATORS DSD EDGE) INSPECTION AND ENVIRONMENTAL INVESTIGATION. BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS, REPROCESSING PROCEDURE REVIEW AND DESTRUCTIVE SAMPLING) IMPROPER REPROCESSING PROCEDURES AND GLUE CONDITION CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, HOWEVER, OLYMPUS WILL CONTINUE TO INVESTIGATE. AS PART OF OUR INVESTIGATION, OLYMPUS DISPATCHED AN ENDOSCOPY SUPPORT SPECIALIST (ESS) TO THE USER FACILITY TO INVESTIGATE THE USER FACILITY¿S REPROCESSING OF THIS SCOPE. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, HOWEVER, IF ADDITIONAL INFORMATION BECOMES OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR THE FOLLOWING MICROORGANISMS: KLEBSIELLA PNEUMONIAE AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030318 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 AER MEDIVATOR DSD EDGE