BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 12707013 · Received October 27, 2021

    Report

    Report Number
    8010047-2021-13717
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 23, 2021
    Report Date
    January 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170339196
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE OLYMPUS CONTAMINATED ENDOSCOPE QUESTIONNAIRE FOR THE SUBJECT DEVICE AND PROVIDED THE FOLLOWING INFORMATION. NO PATIENT INFECTIONS OCCURRED. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER)/ENDOSCOPE WASHER DISINFECTOR (EWD) WAS NOT TESTED. PRE-CLEANING STEPS INCLUDED FLUSHING ALL CHANNELS (AIR/WATER CHANNEL, AUXILARY WATER CHANNEL, BALLOON CHANNEL, AND FORCEPS ELEVATOR WIRE CHANNEL). NO DETERGENT IS USED DURING PRE-CLEANING. THE MODEL OF THE EWD IS ETD-4 AND IT IS USED WITH OLYMPUS DETERGENT AND DISINFECTANT DURING MANUAL CLEANING. THE ENDOSCOPES ARE STORED IN THE EDC DRYING CABINET. MAINTENANCE AND REPAIR IS PERFORMED BY OLYMPUS. THE ENDOSCOPE WAS NOT STERILIZED. THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY FOR MICROBIAL TESTING. THE RESULTS SHOWED MICROBIAL CONTAMINATION OF ALL CHANNELS WITH ONE (1) COLONY FORMING UNIT OF STAPHYLOCOCCUS WARNERI. THE SUBJECT DEVICE WAS REPROCESSED A SECOND TIME AND THE SUBJECT DEVICE WAS TESTED AGAIN. THE RESULTS WERE NEGATIVE FOR MICROBIAL CONTAMINATION. THE DEVICE WAS ALSO EVALUATED. THE FINDINGS INCLUDED THE EYEPIECE RING PARTIALLY DAMAGED AND THE INSERTION PART CONNECTING TUBE IS BROKEN. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE REPROCESSING ENVIRONMENT WAS REVIEWED AND IT WAS CONFIRMED THE CUSTOMER DID NOT FOLLOW THE MANUAL INSTRUCTIONS FOR REPROCESSING: -DETERGENT WAS NOT USED AT PRECLEANING. -STERILIZATION WAS NOT CONDUCTED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO INSUFFICIENT REPROCESSING. AS STATED IN THE INSTRUCTIONS FOR USE, REPROCESSING MANUAL:1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS THE SUBJECT DEVICE TESTED POSITIVE FOR MICROBIAL GROWTH ON (B)(6) 2021 AND THE RESULTS WERE STREPTOCOCCUS SPECIES, EIGHT (8) COLONY FORMING UNITS AND NEISSERIA SPECIES, FOUR (4) COLONY FORMING UNITS. REQUESTS FOR ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600882 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-P60 04953170339196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS ETD-4, UNKNOWN SERIAL