BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 10760154 · Received October 30, 2020

    Report

    Report Number
    8010047-2020-08312
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    April 16, 2020
    Report Date
    December 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170024467
    PMA / PMN Number
    K993041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO CORRECT THE PROCODE FOR MDR 8010047-2020-08312. THE PROCODE SHOULD BE FAJ AS OPPOSED TO RHB.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THE FOLLOWING FIELDS HAVE BEEN POPULATED: A1, D4, D5, D8. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 16-APR-2020. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED FOR A CORRECTION TO H1 AND UPDATES IN G2 AND H6.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. OMSC CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS NOT DUPLICATED. IN ADDITION, THERE WAS NO ABNORMALITY IN VISUAL INSPECTION AND OPERATION CHECK. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO A TEMPORARY CONTACT UNSTABLENESS DUE TO THE EXCEEDED INRUSH CURRENT WHEN THE POWER WAS TURNED ON. 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 PREPARATION FOR AN UNSPECIFIED PROCEDURE AT THE USER FACILITY, IT WAS FOUND THAT THE SUBJECT DEVICE COULD NOT BE TURNED THE POWER ON. THEREFORE, THE INTENDED PROCEDURE HAD TO BE CANCELLED AND POSTPONED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230904 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CLH-SC 04953170024467
    1230910 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CLH-SC 04953170024467

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown