BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 14054613 · Received April 8, 2022

    Report

    Report Number
    8010047-2022-05975
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 9, 2022
    Report Date
    July 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335174
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT INFORMATION PROVIDED IN THE INITIAL REPORT AND TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    AN OLYMPUS FIELD SERVICE ENGINEER PERFORMED AN ONSITE VISIT IN ORDER TO INVESTIGATE THE REPORTED EVENT. THE FSE ASSIGNED THE CAUSE TO A BF-P190 SCOPE AND THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION/REPAIR. THE INVESTIGATION IS ONGOING AND THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    ADDITIONAL CLARIFICATION FROM CUSTOMER RECEIVED REGARDING THE INVOLVED DEVICES: (B)(6): BF-P190, SN:(B)(4)WITH FROZEN SCREEN AND BLACKOUT. CONCOMITANT: CV-190, SN:(B)(4), CV-1500, SN:(B)(4). (B)(6): CV-190, SN:(B)(4) WITH IMAGE FREEZING AND BF-P190, 2812183 WITH FROZEN SCREEN AND BLACKOUT. CONCOMITANT: BF-P190, SN:(B)(4), CV-1500 SN:(B)(4). (B)(6): BF-H190, SN: (B)(4)WITH HALF SCREEN BLACKOUT. CONCOMITANT: CV-190, SN:(B)(4), CLV-190, SN:(B)(4). (B)(6): CV-190, SN:(B)(4)WITH HALF SCREEN BLACKOUT. CONCOMITANT: BF-H190, SN: (B)(4), CLV-190, SN: (B)(4).

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER, THE SUBJECT DEVICE WAS A REPLACEMENT DEVICE THAT WAS USED TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. THERE WAS NO COMPLAINT REPORTED BY THE CUSTOMER RELATED TO THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS DURING A DIAGNOSTIC BRONCHOSCOPY WITH BIOPSY PROCEDURE, THE IMAGE FROZE AND BLACKED OUT WHEN THE PHYSICIAN WAS TAKING THE BIOPSY TISSUE SAMPLE. THE FACILITY INSPECTED THE SCOPE PRIOR TO THE PROCEDURE AND THERE WERE NO ISSUES. THE FACILITY CYCLED THE SYSTEM POWER SWITCH THREE (3) TIMES AND THE ISSUE PERSISTED. THE FACILITY CHANGED TO A DIFFERENT CV-190 SYSTEM AND AFTER POWERING ON, THE IMAGE WAS HALF BLACKED OUT BUT THE PHYSICIAN COULD REMOVE THE BRONCHOSCOPE FROM THE PATIENT AND CHANGE TO BF-H190 BRONCHOSCOPE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE PROCEDURAL DELAY DUE TO THIS MALFUNCTION. THERE WAS NO INJURY OR HARM TO THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT INCIDENT. THIS IS REPORT 3 OF 4. REFERENCE REPORT PATIENT IDENTIFIERS #(B)(6), (B)(6) AND (B)(6) FOR ADDITIONAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161756 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-H190 04953170335174

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female CLV-190 SN:(B)(4)| CV-1500 SN: (B)(4)| CV-190 SN:(B)(4)| CV-190 SN:(B)(4)| LMD-2765MD MONITOR SN:(B)(4)| OEV-321UH MONITOR SN:(B)(4)