BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 13942790 · Received March 29, 2022

    Report

    Report Number
    8010047-2022-05246
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Report Date
    August 31, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS EVALUATED. DEVICE INSPECTION FOUND DIRT AROUND FORCEPS ELEVATOR. ADDITIONALLY, DUE TO BREAKAGE OF LG (LIGHT GUIDE) BUNDLE, ILLUMINATION IS UNEVEN . THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. FURTHERMORE, THE FOLLOWING FINDINGS WERE NOTED ON THE DEVICE DURING INSPECTION: DUE TO DEFORMATION OF U/D KNOB, WATER TIGHTNESS IS LOST DUE TO DEFORMATION OF CONTROL UNIT, WATER TIGHTNESS IS LOST DUE TO A PINHOLE ON A-RUBBER, WATER TIGHTNESS IS LOST ADHESIVE ON A-RUBBER IS DETACHED CONNECTING TUBE HAS COATING PEELING, S-CYLINDER SHAVED UNIVERSAL CORD HAS A SCRATCH DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN ALL DIRECTIONS DOES NOT MEET THE STANDARD VALUE DUE TO DEFORMATION OF NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE C-COVER IS DIRTY ADHESIVE AROUND LG LENS HAS DISCOLORATION , CONTROL UNIT HAS DEFORMATION INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION TO B5 OF THE INITIAL MEDWATCH. THE FOLLOWING INFORMATION WAS RECEIVED. THE CUSTOMER PERFORM THE CDS ACTIVITY, AS PER OUR TRAINING / IFU. THERE ARE MULTIPLE USERS AND DIFFERENT CDS STAFF IN HOSPITAL. THERE IS A POSSIBILITY OF THE EXTENT AND EFFICACY OF THE CDS STEPS. THE USAGE OF DEVICE WITH THE FOREIGN MATERIAL PRESENCE IS NOT CONFIRMED. THERE IS NO PATIENT IMPACT OR INFECTION REPORTED, DUE TO THE EVENT. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE (B)(6) 2022. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS, SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY IFU RECOMMENDED REPROCESSING STEPS WERE NOT PERFORMED COMPLETELY, DUE TO LEAK FROM THE DEVICE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE, WHICH STATE: "ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE ELEVATOR WIRE CHANNEL WHERE FITTED, 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". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER SENT A REPAIR REQUEST WITH AN ISSUE OF INSUFFICIENT LIGHT FROM THE LIGHT GUIDE LENS. THE ISSUE FOUND DURING AN UNKNOWN EVENT. DEVICE EVALUATION FOUND DIRT , FORCEPS ELEVATOR HAS FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATERIAL FOUND ON THE FORCEPS ELEVATOR DURING DEVICE EVALUATION.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED. THE CUSTOMER PERFORM THE CDS ACTIVITY, AS PER OUR TRAINING / IFU. THERE ARE MULTIPLE USERS AND DIFFERENT CDS STAFF IN HOSPITAL. THERE IS A POSSIBILITY OF THE EXTENT AND EFFICACY OF THE CDS STEPS. THE USAGE OF DEVICE WITH THE FOREIGN MATERIAL PRESENCE IS NOT CONFIRMED. THERE IS NO PATIENT IMPACT OR INFECTION REPORTED, DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730941 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown