BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 12708475 · Received October 27, 2021

    Report

    Report Number
    8010047-2021-13729
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 4, 2021
    Report Date
    December 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OMSC CONFIRMED THE SUBJECT DEVICE AND FOUND THAT THE PART CONNECTING THE FORCEPS ELEVATOR AND THE FORCEPS ELEVATOR WIRE HAD COME OFF SINCE THE FORCEPS ELEVATOR WIRE WAS BROKEN. THERE IS A POSSIBILITY OF FATIGUE FRACTURE DUE TO REPEATED STRESS BASED ON THE ANALYSIS OF THE WIRE FRACTURE SURFACE. THE EXACT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) SURMISED THAT THE REPORTED PHENOMENON OCCURRED DUE TO THE FOLLOWING CAUSES. - USED THICK AND STIFF ENDO THERAPY ACCESSORIES, WHICH WERE OUT OF SPECIFICATIONS - THE FORCEPS WAS RAISED WITH EXCESSIVE FORCE - THE FORCEPS ELEVATOR WAS RAISED TO THE MAXIMUM WHILE ENDO THERAPY ACCESSORIES WERE FORCIBLY INSERTED AND WITHDRAWN. - THE DEVICE WAS LEFT AND STORED WITH THE FORCEPS ELEVATOR BEING RAISED.

    Additional Manufacturer Narrative · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WILL START EVALUATING THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WITH THE SUBJECT DEVICE, WHEN QUARRYING WAS PERFORMED NEAR THE DUODENAL PAPILLA, THE FORCEPS ELEVATOR WIRE OF THE SUBJECT DEVICE FRAYED. THE USER REPLACED THE SUBJECT DEVICE WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE DISTAL COVER WAS PROPERLY ATTACHED TO THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS USED IN COMBINATION WITH OLYMPUS VORTICCATCHV AND BOSTON RETRIEVAL BALLOON. THERE WERE NO ABNORMALITIES IN THE ACCESSORIES. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605731 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown