BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 11876604 · Received May 25, 2021

    Report

    Report Number
    8010047-2021-06717
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Report Date
    July 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    PMA / PMN Number
    K993041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC). OMSC COULD NOT REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE BECAUSE MORE THAN FIFTEEN YEARS HAD PASSED SINCE THE SUBJECT DEVICE HAD BEEN MANUFACTURED. BASED UPON THE INFORMATION FROM SORC, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING. THE EXTERNAL FORCE WAS APPLIED TO THE SUBJECT DEVICE. (FOR EXAMPLE, HITTING THE HARD OBJECT TO THE SUBJECT DEVICE, STRONG FORCE BEING APPLIED TO THE TOP COVER AND SO ON). CONSEQUENTLY, THE LAMP ACCESS COVER AND THE TOP COVER WERE DEFORMED AND THE LAMP ACCESS COVER COULD NOT BE CLOSED NORMALLY, THEN THE POWER OF THE SUBJECT DEVICE COULD NOT BE TURNED ON. POWER OF CLH-SC CAN BE TURNED ON WITH CLOSING THE LAMP ACCESS COVER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC). SORC CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE DEFORMATION OF THE LAMP COVER AND THE TOP COVER. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE INSPECTION BEFORE USE, THE SUBJECT DEVICE COULD NOT BE TURNED ON DUE TO THE DEFORMATION OF THE LAMP COVER. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774253 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORP. CLH-SC

    Patients

    Seq Age Sex Outcome Treatment
    1