BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')

    MDR report key: 19563392 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-06026
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    October 14, 2022
    Report Date
    June 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    UDI-DI
    00888867029408
    PMA / PMN Number
    K901035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.

    Description of Event or Problem · 0

    ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3240-5027 FUSED LIGHT CABLE IS GETTING REALLY HOT DURING PROCEDURES. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185129 FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') LIGHT, SURGICAL, FIBEROPTIC FST ARTHREX, INC. FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') WO150554 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown