BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 14547442 · Received May 31, 2022

    Report

    Report Number
    8010047-2022-09106
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    February 21, 2022
    Report Date
    September 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. THE AIR/WATER CHANNEL, AUXILIARY CHANNEL, BALLOON CHANNEL, AND FORCEPS ELEVATOR CHANNEL WERE FLUSHED WITH DDN 7585 DETERGENT. THERE WAS AN ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AS WELL. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, BALLOON CHANNEL, AND INSTRUMENT CHANNEL PORT AND DISTAL END/AREAS AROUND THE ELEVATOR WERE MANUALLY CLEANED WITH DDN 7585 DETERGENT AND NOVACLEAN BRUSHES (LOT #2021070634VCBK). THE SCOPE WAS MANUALLY DISINFECTED WITH DDN 7585. THE AER USED WAS A SOLUSCOPE SERIES 4 (SERIAL # (B)(4)) ALONG WITH SOLUSCOPE DETERGENT (REF # C2240122E024195) AND SOLUSCOPE P (REF # C1031221D354815) DISINFECTANT. THE SCOPE WAS STORED IN A PLASMATYPHOON (REF # 046TD). THE MAINTENANCE OF THE SCOPE WAS PERFORMED BY OLYMPUS. THE SCOPE WAS STERILIZED IN A NOVACLEAN (REF # 2021070634VCBK) AND A SOLUSCOPE SERIES 4 (SERIAL # (B)(4)) EACH PROCEDURE.AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED. THREE (3) CFUS OF BACILLUS SPECIES MESOPHILES AND COAGULASE-NEGATIVE STAPHYLOCOCCI WERE FOUND. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. HOWEVER, DURING INSPECTION WEAR AND TEAR OF THE DEVICE WAS NOTED. THE FOLLOWING WAS ALSO CONFIRMED: ¿CONTROL UNIT /UP DOWN PLATE/GET LOOSEN: FAILED.¿ A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE IDENTIFIED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, NO DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU) WAS CONFIRMED FROM THE REVIEW OF THE REPROCESSING STEPS PROVIDED FROM THE USER. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, A ROUTINE MICROBIOLOGICAL CULTURE WAS PERFORMED ON ALL CHANNELS OF THE EVIS EXERA III COLONOVIDEOSCOPE. THE SCOPE TESTED POSITIVE FOR GREATER THAN SIXTY-THREE (63) COLONY FORMING UNITS (CFUS) OF MICROORGANISMS. THERE WAS NO CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678560 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown