BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8198209 · Received December 26, 2018

    Report

    Report Number
    2951238-2018-00809
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    October 2, 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 PROVIDE ADDITIONAL INFORMATION. OLYMPUS ENGINEER WAS DISPATCHED TO THE HOSPITAL TO REVIEW THE SAMPLING TECHNIQUE OF THE SAMPLER AND THE FACILITATOR WHO TOOK THE SAMPLE FROM THE SCOPE. THE FOLLOWING DEVIATIONS WERE NOTED DURING THE AUDIT. CARDBOARD WAS BROUGHT IN THE SAMPLING ROOM. SAMPLER DID NOT WEAR APPROPRIATE PPE AND GROVE. PERSONNEL NOT RELATED TO SAMPLING WAS PRESENT BUT NOT WEARING APPROPRIATE PPE. OLYMPUS PERSONNEL INSTRUCTED THE APPROPRIATE TECHNIQUE TO THE SAMPLING STAFF. OLYMPUS INVESTIGATIONS IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 ADDITIONAL INFORMATION AND TO UPDATE THE AS PART OF THE POST MARKET SURVEILLANCE STUDY PROCESS, THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO REVIEW THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND FOUND THE TECHNICIAN WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING AND IS NOT PERFORMING PROPER CLEANING TO THE ELEVATOR AT THE DISTAL END. THE ESS OBSERVED THE USER FACILITY IS: NOT USING OLYMPUS CHANNEL CLEANING/OPENING CLEANING BRUSHES. CUSTOMER USES ANOTHER MANUFACTURER'S BRUSH. NOT USING SUCTION CLEANING ADAPTER AFTER BRUSHING CHANNELS WITH CHANNEL LEANING/OPENING CLEANING BRUSHES. CUSTOMER IS DOING THIS AS LAST STEP. NOT RAISING AND LOWERING THE ELEVATOR THREE TIMES WHILE BRUSHING AROUND ELEVATOR AND DISTAL END. NOT PROPERLY BRUSHING THE DISTAL END AROUND THE ELEVATOR WITH THE MAJ-1534 FOR THE TJF-160VF SCOPE. NOT FLUSHING THE ELEVATOR WIRE CHANNEL WITH THE WASHING TUBE PRIOR TO SCOPE BUDDY ON THE TJF-160VF SCOPE. NOT FLUSHING PROPERLY AROUND THE ELEVATOR WITH A SYRINGE WITH DETERGENT AND RINSE WATER. THE ESS CONCLUDED BY RECOMMENDING THE USER FACILITY FOLLOW THE CORRECT REPROCESSING STEPS IN ORDER ACCORDING THE INSTRUCTION/REPROCESSING MANUAL.

    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 ENVIRONMENTAL INVESTIGATION AND THE INSPECTION OF THE AUTOMATED ENDOSCOPE REPROCESSOR. THE USER FACILITY UTILIZED A MEDIVATORS DSD EDGE TO REPROCESS THIS SCOPE. A SCOPE INSPECTION WAS NOT CONDUCTED BECAUSE THE SITE RELEASED THE SCOPE FOR CLINICAL USE WITHOUT CONDUCTING SCOPE INSPECTION VIA THEIR OWN ACCORD. THE SCOPE WAS REPORTEDLY USED EIGHT TIMES AFTER RELEASE. THERE WAS NO HIGH CONCERN ORGANISMS OR LEAKS WERE DETECTED FOLLOWING THOSE CASES. BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS AND SAMPLING REVIEW), INSUFFICIENT/IMPROPER REPROCESSING PROCEDURES 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. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, HOWEVER, OLYMPUS WILL CONTINUE TO INVESTIGATE. AS PART OF OUR INVESTIGATION IN THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO INVESTIGATE THE USER FACILITY¿S REPROCESSING PRACTICES. 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 MICROORGANISMS, BREVUNDIMONAS INTERMEDIA/VESICULARIS AND BREVUNDIMONAS NASDAE AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036925 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 AER: MEDIVATORS DSD EDGE