BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 13081715 · Received December 23, 2021

    Report

    Report Number
    8010047-2021-16765
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 10, 2021
    Report Date
    April 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. 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. 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 INCORRECT REPROCESSING. AS STATED IN THE INSTRUCTIONS FOR USE, CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES WARNING ALL CHANNELS OF THE ENDOSCOPE, INCLUDING BALLOON CHANNEL WHERE EXISTING, MUST BE CLEANED AND HIGH-LEVEL DISINFECTED OR STERILIZED DURING EVERY REPROCESSING CYCLE, EVEN IF THE CHANNELS WERE NOT USED DURING THE PREVIOUS PATIENT PROCEDURE. OTHERWISE, INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THE ENDOSCOPE MAY POSE AN INFECTION-CONTROL RISK TO THE PATIENT AND/OR OPERATORS PERFORMING THE NEXT PROCEDURE WITH THE ENDOSCOPE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED OLYMPUS TO REPORT TWO PATIENTS HAD A HIGH FEVER AND SHAKING CHILLS AFTER USED OF OLYMPUS ENDOSCOPES AND ONE OF THEIR REPROCESSORS TESTED POSITIVE FOR MICROBIAL CONTAMINATION. A PATIENT PRESENTED WITH A HIGH FEVER AND SHAKING CHILLS AFTER AN UNSPECIFIED PROCEDURE WITH BF-XT160, SN (B)(4) WHICH IS REPORTED IN (B)(4). THEN A SECOND PATIENT HAD AN UNSPECIFIED PROCEDURE WITH TWO DIFFERENT ENDOSCOPES: BF-P180 SN:(B)(4) & BF-UC180F EBUS SN:(B)(4). AFTER A FEW MINUTES, THE PATIENT PRESENTED WITH A HIGH FEVER AND SHAKING CHILLS. (B)(6) ADDRESSES BF-P180 SN:(B)(4) AND (B)(6) ADDRESSES BF-UC180F EBUS SN:(B)(4). AFTER THE TWO PATIENTS EXPERIENCED THESE SYMPTOMS, THE CUSTOMER PERFORMED A MICROBIOLOGICAL TEST ON THE FOUR (4) ETD MACHINES IN REPROCESSING. ONE (1) OF THE FOUR (4) TESTED POSITIVE FOR MICROBIAL CONTAMINATION WITH PSEUDOMONAS AERUGINOSA AND IS CAPTURED IN (B)(6) FOR MINI ETD PLUS VERSION MODEL 025509, SN (B)(4). THE OPERATOR OF THE INSTRUMENT CONFIRMED THE ENDOSCOPE BF-P180 SN:(B)(4) CAPTURED IN (B)(6) HAD BEEN REPROCESSED INSIDE MINI ETD PLUS SN:(B)(4) PRIOR TO IT TESTING POSITIVE FOR MICROBIAL CONTAMINATION. NO MICROBIOLOGICAL TESTS WERE PERFORMED ON THE INSTRUMENT BF-P180 SN:(B)(4) AND CURRENTLY IT IS IN USE. MICROBIOLOGICAL TEST WERE DONE ON THE BRONCHOASPIRATE AND IT TESTED POSITIVE FOR MICROBIAL CONTAMINATION WITH COMAMONAS TESTOSTERONE. AFTER RECEIPT OF THE MICROBIAL CONTAMINATION RESULTS FOR THE ONE (1) ETD MACHINE, ALL ENDOSCOPES IN THE DEPARTMENT WERE IMMEDIATELY WASHED, DECONTAMINATED, AND HIGHLY DISINFECTED WITH STERIS 20 CONCENTRATED STERILANT REF S2009. THERE ARE 3 REPORTS INVOLVED WITH THIS EVENT: (B)(6) IS FOR BF-XT160, SN (B)(4) ASSOCIATED WITH PATIENT 1. (B)(6) IS FOR BF-P180 SN:(B)(4) ASSOCIATED WITH PATIENT 2. (B)(6) IS FOR BF-UC180F EBUS SN:(B)(4) ASSOCIATED WITH PATIENT 2. THIS IS REPORT 3 OF 3 FOR PATIENT IDENTIFIER (B)(6) IS FOR BF-UC180F EBUS SN:(B)(4) ASSOCIATED WITH PATIENT 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971563 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other