BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSCOPE CONSOLE

    MDR report key: 19509247 · Received June 11, 2024

    Report

    Report Number
    1220246-2024-05531
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 11, 2021
    Report Date
    July 2, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867299580
    PMA / PMN Number
    K201134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    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. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE, THAT NO PROBLEM WAS FOUND.

    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. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. MANUFACTURING DATE 2018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AR-3200-0030, CANNOT BOOT AND ORANGE LIGHT LIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295876 NANOSCOPE CONSOLE LAPAROSCOPE GCJ ARTHREX, INC. NANOSCOPE CONSOLE 201842 00888867299580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown