BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8104504 · Received November 26, 2018

    Report

    Report Number
    2951238-2018-00724
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    October 14, 2018
    Report Date
    August 14, 2019
    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 ADDITIONAL INFORMATION AND TO UPDATE THE FOLLOWING SECTIONS: G4, G7, H2, H6 AND H10. AS PART OF THE PMS STUDY PROCESS, SCOPE INSPECTION WAS PERFORMED AT THIRD PARTY LABORATORY. BELOW IS THE SUMMARY CASE REPORT FOR THIS SCOPE. THE SUMMARY OF THE INVESTIGATION FINDINGS ARE AS FOLLOWS; -THE ORGANISMS IDENTIFIED WERE NEOSARTORYA FISCHERI AND HAMIGERA AVELLANEA, WHICH ARE MOLD AND NOT HUMAN RESIDENT FLORA. -SOME IMPROPER ASEPTIC TECHNIQUES DURING SAMPLING WERE REPORTED BY THE ON-SITE INFECTION CONTROL NURSE. -MULTIPLE DEVIATIONS WERE OBSERVED DURING THE REPROCESSING PROCEDURE REVIEW. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THIS PHENOMENON WAS POSSIBLY OCCURRED DUE TO FOLLOWING; -PROBABLY ENVIRONMENTAL CONTAMINATION ORIGINATING FROM IMPROPER ASEPTIC TECHNIQUES DURING SAMPLING BECAUSE OF THE TYPE OF SPECIES OBSERVED (MICROBIOLOGICAL ANALYSIS). -WHILE INADEQUATE REPROCESSING IS PROBABLY NOT THE PRIMARY CAUSE, IT CANNOT BE COMPLETELY RULED OUT DUE TO THE DEVIATIONS REPORTED (REPROCESSING PROCEDURE REVIEW).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND FOUND THE TECHNICIAN WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING AND WAS NOT PERFORMING PROPER CLEANING TO THE ELEVATOR AT THE DISTAL END AREA. THE TECHNICIAN WAS NOT: USING OLYMPUS CHANNEL CLEANING/OPENING CLEANING BRUSHES AND USES NON-OLYMPUS BRUSHES. NOT USING A SUCTION CLEANING ADAPTER AFTER BRUSHING CHANNELS AND 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 USING MEDIVATOR 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 CONDUCTING A REPROCESSING IN-SERVICE TRAINING THAT INCLUDED ALL CLEANING, DISINFECTION AND STERILIZATION INFORMATION THAT IS CONTAINED IN THE OLYMPUS REPROCESSING/INSTRUCTION MANUAL. ADDITIONALLY, AS PART OF THE PMS STUDY PROCESS, OLYMPUS PERSONNEL CONDUCTED A REVIEW OF THE TECHNIQUE OF THE SAMPLER WHO TOOK THE SAMPLE FROM THE SCOPE. AND NO DEVIATIONS WERE FOUND.

    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, 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: NEOSARTORYA FISCHERI AND HAMIGERA AVELLANEA AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT THE CLEANING AND DISINFECTANT SOLUTIONS USED WITH THE ENDOSCOPE ARE MEDIVATORS INTERCEPT AND PERACETIC ACID STERIS. THE MINIMUM EFFECTIVE CONCENTRATION IS BEING CHECKED BEFORE REPROCESSING EACH SCOPES. DURING MANUAL CLEANING, THE ENDOSCOPE CHANNEL IS BEING BRUSHED USING A SINGLE USE, ENDOCHOICE HEDGEHOG BRUSH. PRE-CLEANING IS BEING PERFORMED BY FOLLOWING IFU RECOMMENDATIONS. ALL SCOPES ARE BEING LEAK TESTED USING OLYMPUS MU-1. THE USER FACILITY UTILIZES THE STERIS 1E AUTOMATED ENDOSCOPE REPROCESSOR (AER) AND WAS IT REPORTED TO BREAK DOWN FREQUENTLY. IT IS UNKNOWN WHEN THE LAST PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE STERIS 1E. A TRAINING IN REPROCESSING IN-SERVICE WAS LAST CONDUCTED BY THE ESS AT THE USER FACILITY ON (B)(4) 2018. THERE HAVE BEEN NO REPROCESSING PERSONNEL CHANGES SINCE THE LAST VISIT. THE SCOPES ARE STORED IN A STORAGE CABINET, HANGING VERTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940249 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 AER-STERIS 1E.| BRUSH-ENDOCHOICE HEDGEHOG.| CLEANING SOLUTION-MEDIVATORS INTERCEPT.| DISINFECTANT-PARACETIC ACID STERIS.| LEAK TESTER-OLYMPUS MU-1.