BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19354458 · Received May 20, 2024

    Report

    Report Number
    1220246-2024-03548
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    February 16, 2021
    Report Date
    May 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    UDI-DI
    00888867029408
    PMA / PMN Number
    K901035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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 COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PHOTO, WHICH SHOWS THAT THE CONNECTOR HAD CORROSION AROUND METAL PARTS AND BURNED THE OPTIC FIBERS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO COMPLAINT ENVIRONMENTAL DUE TO MOISTURE INTRUSION IN THE CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIGHT GUIDE CABLE IS BURNED THROUGH ON THE SIDE WHERE THE OPTICS ARE CONNECTED. THERE IS NO DAMAGE TO THE OPTICS ITSELF. THE PROBLEM WAS NOTICED AFTER THE SURGERY/ TREATMENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452507 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') WO150138 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown