BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 12600638 · Received October 8, 2021

    Report

    Report Number
    8010047-2021-12936
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 16, 2021
    Report Date
    November 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356322
    PMA / PMN Number
    K011314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, AND THE PRESENCE OF SCRATCHES IN THE AREA, IT IS LIKELY THAT AN EXTERNAL FORCE WAS APPLIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE CAUTION DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION TUBE, PARTICULARLY THE ULTRASONIC TRANSDUCER AND THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AT THE OLYMPUS SERVICE CENTER, THE CUSTOMER¿S ISSUE WAS NOT CONFIRMED. THE SCOPE IMAGE WORKED AS INTENDED. THE BENDING SECTION, INSERTION TUBE, AND S-CONNECTOR WERE MANIPULATED, AND THE IMAGE WORKED AS INTENDED. THE CHARGED-COUPLE DEVICE (CCD) UNIT WAS BURNED FOR TWENTY (20) MINUTES AND THE IMAGE WORKED AS INTENDED. THE S-CONNECTOR WAS OPENED, AND NO FLUID INVASION WAS FOUND. THE BIOPSY CHANNEL WAS LEAKING DUE TO AN INTERNAL CUT. THE LIGHT GUIDE COVER GLUE WAS PEELING. THE BENDING SECTION COVER HAD A CRACK. THE INSERTION TUBE HAD BUCKLES. THE OBJECTIVE LENS HAD A CHIP AT THE EDGE, BUT THE IMAGE WAS NOT AFFECTED. THE ULTRASOUND IMAGE HAD THREE (3) BROKEN ELEMENTS. THE LIGHT GUIDE TUBE/CABLE HAD BUCKLES AND SCRATCHES. THE CUSTOMER¿S LABEL WAS INCORRECT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE, THE ULTRASONIC GASTROVIDEOSCOPE PRESENTED A BLACK IMAGE. NO PATIENT HARM REPORTED. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THE LIGHT GUIDE COVER GLUE WAS PEELING. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE PEELING LIGHT GUIDE COVER GLUE NOTED AT ESTIMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498498 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UC140P-AL5 04953170356322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown