BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 19554183 · Received June 17, 2024

    Report

    Report Number
    1220246-2024-05902
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 16, 2023
    Report Date
    June 17, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    PMA / PMN Number
    K901035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. ACCORDING TO THE LIT-021 ARTHREX 950-0031-00 K IFU ARTHREX LIGHT GUIDES, REVISION K. 4. WARNINGS AND PRECAUTIONS. WARNING: RISK OF BURNS! THE OPTICAL FIBERS EMIT HIGH-ENERGY LIGHT AT THE DISTAL END OF THE FIBER-OPTIC CABLE. THIS CAN CAUSE THE TEMPERATURE OF THE BODY TISSUE TO RISE TO 106 °F (41°C). THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO PROBLEM FOUND. THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT.

    Description of Event or Problem · 0

    ON 05/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 LIGHT GUIDE IS GETTING OVERHEATED, ALSO CAUSING THE CAMERA TO HEAT HOT TO THE TOUCH. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332320 UNK LIGHT, SURGICAL, FIBEROPTIC FST ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown