BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19369337 · Received May 22, 2024

    Report

    Report Number
    1220246-2024-03621
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    October 28, 2022
    Report Date
    May 22, 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 REPORTED EVENT WAS CONFIRMED AS THE EVALUATION REVEALED THE LIGHT GUIDES ON THE CONNECTION TO THE OPTICS HAS SIGNS OF BURNS WHICH COULD CAUSES BY OVERHEATING. FURTHER THE CONNECTION TO THE CONSOLE IS DAMAGED AND THE LASER MARKS ON THE HANDLE ARE FADED. THE DEVICE WAS TESTED AND THE LIGHT CONDUCTIVITY SHOWS 0%. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE APPROACH IS BURNT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451645 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') WO175979 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown