BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE POSITION DETECTING UNIT

    MDR report key: 17611416 · Received August 24, 2023

    Report

    Report Number
    3002808148-2023-08873
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 10, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PGU
    UDI-DI
    04953170331145
    PMA / PMN Number
    K134026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THE SUBJECT DEVICE DISPLAYED ERROR CODE N907; HOWEVER; PER THE LEGAL MANUFACTURER, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ENDOSCOPE POSITION DETECTING UNIT DISPLAYED ERROR CODE N907 (IMAGE PROCESSOR/LIGHT SOURCE DEFECT). THE ERROR WAS NOTICED BEFORE A DIAGNOSTIC PROCEDURE ON THE SCOPE GUIDE. THERE WAS A DELAY OF MORE THAN 15 MINUTES AND THE PROCEDURE WAS COMPLETED WITHOUT SCOPE GUIDE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56031 ENDOSCOPE POSITION DETECTING UNIT ENDOSCOPE POSITION DETECTING UNIT PGU SHIRAKAWA OLYMPUS CO., LTD. UPD-3 04953170331145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown