BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8198208 · Received December 26, 2018

    Report

    Report Number
    2951238-2018-00810
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 3, 2018
    Report Date
    May 19, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    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. AS PART OF THE POST MARKET SURVEILLANCE STUDY INVESTIGATION, AN OLYMPUS ENGINEER WAS DISPATCHED TO OBSERVE THE SAMPLING TECHNIQUE OF THE SCOPE SAMPLER AND THE FOLLOWING OBSERVATIONS WERE NOTED: SOMEONE WAS ENTERING OR LEAVING THE SAMPLING ROOM. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME, BECAUSE THE INVESTIGATION OF THIS CASE IS ONGOING.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. 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 OBSERVED THE TECHNICIAN WAS NOT BRUSHING THE CORRECT AREAS WITH THE CHANNEL OPENING CLEANING BRUSH AROUND THE ELEVATOR AND THE MAJ-1534 CLEANING BRUSH AND WAS NOT RAISING AND LOWERING THE ELEVATOR AT THE RECOMMENDED TIMES. 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 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 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 AUTOMATED ENDOSCOPE REPROCESSOR INSPECTION. THE CUSTOMER UTILIZED THE STERIS 1E AER FOR THIS SCOPE. BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS, REPROCESSING PROCEDURE REVIEW, SAMPLING PROCEDURE REVIEW), INSUFFICIENT/IMPROPER REPROCESSING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    AS PART OF THE POST MARKET STUDY, THE SUBJECT SCOPE WAS SENT FOR DESTRUCTIVE SAMPLING AT AN EXTERNAL LABORATORY. THE DESTRUCTIVE SAMPLING DID NOT IDENTIFY ANY HIGH CONCERN ORGANISMS. AFTER THE DISASSEMBLING, THE FOLLOWING WAS OBSERVED: DETERIORATION AND BLEACHING OF THE GLUE OF THE BENDING SECTION. OXIDATION UNDER THE GLUE AROUND THE LIGHT GUIDE LENS. DETERIORATION, DETACHMENT AND BLEACHING OF THE GLUE AROUND THE CAMERA AROUND THE OBJECTIVE LENS. PRESENCE OF WHITE FOAM INSIDE THE AIR/WATER NOZZLE. THE SCOPE WAS THEN SENT TO AN INDEPENDENT LABORATORY FOR ETHYLENE OXIDE (EO) STERILIZATION AND THEN RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION ON THE SCOPE AND YELLOW SUBSTANCE WAS FOUND INSIDE THE INSTRUMENT CHANNEL FROM THE BIOPSY PORT SIDE AND FROM THE BENDING SECTION SIDE. IN ADDITION, THE SUCTION CHANNEL WAS INSPECTED AND FOUND MORE YELLOW SUBSTANCE INSIDE THE SUCTION CHANNEL FROM THE SUCTION CYLINDER SIDE. THE IMAGE WAS CHECKED AND THE IMAGE IS NORMAL. AS A RESULT OF THE DESTRUCTIVE TESTING, THE SCOPE WAS RECEIVED WITHOUT THE DISTAL END COVER AND THE ELEVATOR FORCEPS RAISER, THEREFORE, A LEAK TEST COULD NOT BE PERFORMED. A REVIEW OF THE SCOPE'S INSTRUMENT HISTORY RECORDS INDICATES THE SCOPE WAS LAST REPAIRED ON MAY 17, 2018. THE CAUSE OF THE FOREIGN YELLOW/BROWN SUBSTANCE AND THE REPORTED POSITIVE CULTURE CANNOT BE DETERMINE AT THIS TIME AS THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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, ENTEROCOCCUS FAECIUM, AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035741 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 AER: STERIS