BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EUS ENDOSCOPIC ULTRASOUND CENTER

    MDR report key: 20336948 · Received September 30, 2024

    Report

    Report Number
    3002808148-2024-09405
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    March 27, 2024
    Report Date
    September 30, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    IYN
    UDI-DI
    04953170343414
    PMA / PMN Number
    K203128
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000425.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENDOSCOPIC ULTRASOUND CENTER ONLY SHOWED HALF OF THE ULTRASOUND IMAGE DURING A DIAGNOSTIC PROCEDURE WITH PLANNED BIOPSY. AFTER TROUBLESHOOTING, IT SEEMED TO BE A RANDOM AND ONE-TIME OCCURRENCE, AND THE DEVICE SPONTANEOUSLY BEGAN TO SHOW FULL IMAGE. IT WAS DETERMINED THAT THE SUBJECT DEVICE WAS THE CAUSE OF THE ISSUE. THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS ON THE TABLE AND ALREADY INTUBATED. THE PATIENT WAS RESCHEDULED A WEEK LATER. THE RESCHEDULED PROCEDURE WAS COMPLETED WITH A LOANER ENDOBRONCHIAL ULTRASOUND SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585400 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER IYN SHIRAKAWA OLYMPUS CO., LTD. EU-ME2 PREMIER PLUS 04953170343414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other