BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10217952 · Received July 1, 2020

    Report

    Report Number
    1220246-2020-01939
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 12, 2020
    Report Date
    October 5, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    FST
    UDI-DI
    00888867029408
    PMA / PMN Number
    K901035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. DEVICE WEAR & TEAR. THE EVALUATION DETERMINED THAT THE REPORTED EVENT WAS CAUSED BY THE DEVICE CONDITION.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALCANEUS ARTHROSCOPY THE LIGHT LINE DEVELOPED HEAT AND BURNED THE PATIENT. IT WAS FURTHER REPORTED THAT IT SEEMS THAT THE PATIENT BURNED WAS CAUSED BY USER FAULT OR THE OPTICS. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE PATIENT BURN WAS IDENTIFIED AFTER THE SURGERY WAS FINISHED. UPDATE 29-JUN-2020: FURTHER INFORMATION WAS PROVIDED THAT THE METAL PART OF THE LIGHT WIRE GOT WARM AND BURNT THE PATIENT BECAUSE IT WAS LYING ON THE PATIENT SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684677 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') WO125667 00888867029408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other