BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER MAJ-2315 FOR TJF-Q190V DUODENOSCOPE

    MDR report key: 16435401 · Received February 24, 2023

    Report

    Report Number
    16435401
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    December 14, 2022
    Report Date
    December 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DISPOSABLE TIP THAT IS USED ON THE TJF-Q190V DUODENOSCOPE HAS BEEN DISLODGED/SPLIT ON MULTIPLE OCCASIONS, THE COMPANY INFORMED US THE "NEW IMPROVED TIPS" WOULD NOT HAVE ELIMINATE THE PRESERVED ISSUES. THE PATIENT PRESENTED TO THE ENDOSCOPY DEPARTMENT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. AFTER THE PROCEDURE CONCLUDED, AND DURING POST PROCEDURE EQUIPMENT EVALUATION, A STAFF NOTICED THE DISPOSABLE PLASTIC TIP FROM THE TJF-Q190V DUODENOSCOPE WAS MISSING. THE PATIENT WHO HAD BEEN TRANSITIONED, WAS INFORMED OF THE SITUATION, AND RETURNED TO THE PROCEDURE ROOM FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR EVALUATION OF UNINTENDED RETAINED OBJECT. THE DISPOSABLE SCOPE TIP WAS SEEN IN THE STOMACH AND RETRIEVED WITHOUT ANY ADVERSE EVENTS. THE PATIENT RETURNED TO PRE-PROCEDURE/ PRE-ANESTHESIA LEVEL AND WAS DISCHARGED SAFELY. NOTE: STAFF REPORTS CONTINUED ISSUES WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947047 SINGLE USE DISTAL COVER MAJ-2315 FOR TJF-Q190V DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2315

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Male