BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSCOPE CONSOLE

    MDR report key: 19175169 · Received April 24, 2024

    Report

    Report Number
    1220246-2024-02336
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    May 26, 2021
    Report Date
    June 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867299580
    PMA / PMN Number
    K201134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 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 SOFTWARE ISSUE.

    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A SOFTWARE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AR-3200-0030 NANOSCOPE CONSOLE WAS HAVING TROUBLE WITH THE DICOM SEND AND RECEIVE OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947627 NANOSCOPE CONSOLE LAPAROSCOPE GCJ ARTHREX, INC. NANOSCOPE CONSOLE UNK 00888867299580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown