BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSCOPE CONSOLE

    MDR report key: 19417301 · Received May 29, 2024

    Report

    Report Number
    1220246-2024-04234
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    February 14, 2022
    Report Date
    May 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K201134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE NOT EXPECTED TO RETURN. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON 02/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE AR-3200-0030 NANO CONSOLE THAT WAS ON DISPLAY AT ARTHREX INC IS HAVING AN INTERNAL TECHNICAL ISSUE. DISPLAYING ALL HANDPIECES ARE NOT CAPABLE WITH OUR HANDPIECES. THE SOFTWARE WAS UPDATED HOPING THAT WOULD FIX THE ISSUE, BUT IT DID NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884937 NANOSCOPE CONSOLE LAPAROSCOPE GCJ ARTHREX, INC. NANOSCOPE CONSOLE 201941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown