BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU, ARTHREX SYNERGYUHD4, MATRIX

    MDR report key: 17541959 · Received August 14, 2023

    Report

    Report Number
    1220246-2023-07496
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 17, 2023
    Report Date
    November 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867216549
    PMA / PMN Number
    K153218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. (DEVICE NOT RETURNED) THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A FAILING SMALL FORM-FACTOR PLUGGABLE (SFP) MODULE.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU AND A E830343 ELO 15 INCH WIDESCREEN ARE EXPERIENCING LOST CONNECTION. THEY STATED SYNERGY LOST CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51770 CCU, ARTHREX SYNERGYUHD4, MATRIX LAPAROSCOPE GCJ ARTHREX, INC. CCU, ARTHREX SYNERGYUHD4, MATRIX UNK 00888867216549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown