BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 11647810 · Received April 12, 2021

    Report

    Report Number
    8010047-2021-04822
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 17, 2021
    Report Date
    November 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE " TYPE OF REPORTABLE EVENT." DURING THE REMEDIAL REVIEW OF THIS COMPLAINT IT WAS DISCOVERED THAT A DATA ENTRY ERROR IN SECTION H1 OCCURRED. AS THERE WAS NO PATIENT INVOLVEMENT OR DEATH REPORTED BY THE CUSTOMER, THE TYPE OF REPORTABLE EVENT HAS BEEN DETERMINED TO BE A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, WHILE ONSITE THE ESS COMPLETED A REPROCESSING IN-SERVICE WITH STAFF. THE ESS RECOMMENDED THAT THE CUSTOMER FOLLOW ALL OLYMPUS REPROCESSING PROCEDURES AS DOCUMENTED IN THE ONTRACK FORMS AND REPROCESSING MANUALS. THE SCOPE WILL NOT BE RETURNED FOR EVALUATION. IN ADDITION, THE LEGAL MANUFACTURER REVIEWED THE CONTENT OF THE COMPLAINT. THE LEGAL MANUFACTURER PERFORMED A DHR REVIEW AND CONFIRMED THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOWEVER, THE LEGAL MANUFACTURER PRESUMED THAT HUMAN ERROR MAY HAVE RESULTED IN FAILURE OF FACILITY TO PERFORM ADEQUATE SCOPIC IRRIGATION (BALLOON CHANNEL BRUSHING). ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES CHANNEL CLEANING BRUSH (BW-7B/REUSABLE); SINGLE USE SINGLE-ENDED CLEANING BRUSH (BW-400B); THE CHANNEL CLEANING BRUSH OR THE SINGLE USE SINGLE-ENDED CLEANING BRUSH IS USED TO CLEAN THE BALLOON CHANNEL CLEANING THE BALLOON CHANNEL IN THE INSERTION SECTION (LOCATION E). GRIP THE CHANNEL CLEANING BRUSH (BW-7B) OR THE SINGLE USE SINGLE-ENDED CLEANING BRUSH (BW-400B) AT A POINT 1.5 CM FROM THE DISTAL END. INSERT THE CHANNEL CLEANING BRUSH OR THE SINGLE USE SINGLE-ENDED CLEANING BRUSH INTO THE IRRIGATION PORT AS ILLUSTRATED BY E IN FIGURE 7.20. USING SHORT STROKES, FEED THE BRUSH THROUGH THE INSERTION SECTION UNTIL IT STOPS. IT CAN BE CONFIRMED WHETHER THE BRUSH HAS REACHED THE DISTAL END BY LOOKING AT THE TIP OF BRUSH THROUGH THE GROOVE OF THE BALLOON WATER FEEDING AND SUCTION PORT (ROUGH STANDARD OF BRUSH INSERTION LENGTH: 85 CM FROM POINT). CAREFULLY PULL THE BRUSH OUT THROUGH THE CHANNEL. CLEAN THE BRISTLES WITH YOUR FINGERTIPS IN THE DETERGENT SOLUTION. REPEAT UNTIL ALL DEBRIS IS REMOVED.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED DURING AN IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS) AT THE CUSTOMER¿S SITE, IT WAS NOTED THAT THE SCOPE WAS IMPROPERLY OR INCORRECTLY REPROCESSED AND USED. THE CUSTOMER INFORMED THE ESS, THE FACILITY DOES NOT USE THE RECOMMEND BW-400B SINGLE-ENDED CLEANING BRUSH TO CLEAN THE BALLOON CHANNEL OF THE SCOPE. A CHANNEL OPENING BRUSH IS USED TO CLEAN INSIDE THE CHANNEL. THERE WAS NO PATIENT INFECTION OR DEVICE POSITIVE CULTURE REPORTED. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546042 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown