BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM

    MDR report key: 19316037 · Received May 14, 2024

    Report

    Report Number
    1220246-2024-03271
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867405851
    PMA / PMN Number
    K233451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-3355-4050 SERIAL/BATCH NUMBER 1921519 WAS RECEIVED FOR EVALUATION. THE VISUAL EVALUATION REVEALED THAT THE SHAFT'S TIP WAS DAMAGED. ACCORDING TO THE COMPLAINT, "THE SCOPE WAS NICKED BY A SHAVER AND SUBSEQUENTLY DAMAGED." THE OBSERVED FAILURE IS MOST LIKELY DUE TO MISUSE BY THE END USER.

    Description of Event or Problem · 0

    ON 04/18/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06543064 THAT AN AR-3355-4050 SCOPE GOT NICKED BY A SHAVER AND WAS DAMAGED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483630 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM LAPAROSCOPE GCJ ARTHREX, INC. 4K CMT PANO ARTHROSCOPE,45°,4.2MM X161MM 15174654 00888867405851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown