BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19425349 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04401
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 17, 2023
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    PMA / PMN Number
    K901035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-3240-5027 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. NO FUNCTIONAL TEST WAS PERFORMED FOR THIS DEVICE AS THE LIT-021 ARTHREX 950-0031-00 K IFU ARTHREX LIGHT GUIDES. 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). VISUAL EVALUATION DID NOT FIND ISSUES. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE GOT EXTREMELY HOT AT THE END WHERE IT IS ATTACHED TO THE OPTICS AND THEN ALSO SMELLED BURNT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100100 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') WO181046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown