BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19309898 · Received May 14, 2024

    Report

    Report Number
    1220246-2024-03230
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 22, 2022
    Report Date
    May 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    UDI-DI
    00888867029408
    PMA / PMN Number
    K901035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. PER SUPPLIER EVALUATION A VISUAL INSPECTION FOUND MULTIPLE BROKEN FIBERS AND THE DISTAL CABLE END LENS ARE CRACKED. THE CONDITION OF THE CABLE CONSISTENT WITH QUESTIONABLE USER HANDLING.

    Description of Event or Problem · 0

    ON 04/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-3240-5027 FUSED LIGHT CABLE IS OVERHITTING. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925404 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') WO156351 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown