BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19559189 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-05947
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    March 23, 2021
    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
    MX
    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. SUPPLIER EVALUATION IDENTIFIED MULTIPLE BROKEN FIBERS FROM CUSTOMER DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AR-3240-5027 GOT TOO HOT DURING A CX PROCEDURE FOR THE SURGEON'S COMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310658 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') WO153478 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown