BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 13008059 · Received December 15, 2021

    Report

    Report Number
    2951238-2021-00455
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170403019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO THE OLYMPUS REPRESENTATIVE, AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PLASTIC COVER WAS MISSING FROM THE END OF THE SCOPE. THE SCOPE WAS REINTRODUCED INTO THE PATIENT, THE PLASTIC COVER WAS IDENTIFIED IN THE SECOND PART OF THE DUODENUM AND RETRIEVED USING RAT TOOTH FORCEPS. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER AND NO ADDITIONAL INFORMATION IS AVAILABLE. IT IS UNKNOWN IF THERE WAS PATIENT HARM OR INJURY. THIS EVENT INCLUDES 2 REPORTS: PATIENT IDENTIFIER (B)(6): MAJ-220 315 PATIENT IDENTIFIER (B)(6): TJF Q190V THIS REPORT IS 1 OF 2 FOR PATIENT IDENTIFIER (B)(6): MAJ-220 315.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911596 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2315 2020959 04953170403019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention TJF Q190V