BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO

    MDR report key: 19574205 · Received June 20, 2024

    Report

    Report Number
    1220246-2024-06258
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    October 13, 2021
    Report Date
    June 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867197053
    PMA / PMN Number
    K153218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. (CAMERA HEAD) THE EVALUATION DETERMINED THAT THE REPORTED EVENT WAS CAUSED BY A DEFECTIVE CAMERA HEAD. THIS WAS ATTRIBUTED TO WEAR AND TEAR DUE TO THE AGE OF THE DEVICE.

    Description of Event or Problem · 0

    ON 10/13/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0025 4K HD C-MOUNT CAMERA, IS GETTING VERY WARM/HOT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. THE PATIENT WAS NOT AFFECTED. THE CASE WAS COMPLETED USING A DIFFERENT CAMERA. TS: CHECKED THE LIGHT SOURCE OUTPUT, CHANGED OUT THE LIGHT CORD THINKING IT WAS GOING BAD AND ALSO TESTED THE CAMERA AFTER THE CASE IN WHICH IT STARTED HEATING UP AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511059 4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO LAPAROSCOPE GCJ ARTHREX, INC. 4K SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUTO 00888867197053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown