BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WM-DP2 WORKSTATION SET 1 (US)

    MDR report key: 17102128 · Received June 10, 2023

    Report

    Report Number
    2429304-2023-00188
    Event Type
    Injury
    Date Received
    June 10, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 10, 2023
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT)
    Product Code
    FEM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS NO AIR AND AN INTERMITTENT BLACK SCREEN ON THE EVIS EXERA III XENON LIGHT SOURCE DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WAS NO ERROR MESSAGE OBSERVED AS A RESULT OF THE FAILURE. THE PROCEDURE WAS MOVED TO THE NEXT ROOM TO USE A DIFFERENT WM-DP2 WORKSTATION SET AND LATER, THE LIGHT SOURCE AND EVIS EXERA III VIDEO SYSTEM CENTER WERE PLUGGED INTO THE WALL AND STARTED WORKING. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THE PROBLEM DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. HOWEVER, THE PROCEDURE WAS DELAYED THIRTY MINUTES TO TROUBLESHOOT. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED PROBLEM. NO ADDITIONAL PATIENT HARM WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS ARE RELATED: PATIENT IDENTIFIERS (B)(6) (WM-DP2 WORKSTATION SET - THIS REPORT) AND (B)(6) (EVIS EXERA III XENON LIGHT SOURCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436144 WM-DP2 WORKSTATION SET 1 (US) WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) K10020639 21731924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CV-190 EVIS EXERA III VIDEO SYSTEM CENTER.| EVIS EXERA III XENON LIGHT SOURCE SN: (B)(6).