BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSCOPE HANDPIECE

    MDR report key: 19312930 · Received May 14, 2024

    Report

    Report Number
    1220246-2024-03263
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    March 28, 2022
    Report Date
    May 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867287839
    PMA / PMN Number
    K201134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED 761-0113-02 TROCAR AND TWO 761-0126-02 OBTURATORS FROM AN AR-3210-0040 WERE RECEIVED FOR INVESTIGATION. NO NANOSCOPE HANDPIECE WAS RETURNED. FUNCTIONAL TESTING IDENTIFIED THAT BOTH TROCARS WERE ABLE TO BE MATED WITH THE OBTURATOR. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 03/28/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0040 OBTURATOR DOES NOT FIT IN THE SHEATH. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102651 NANOSCOPE HANDPIECE LAPAROSCOPE GCJ ARTHREX, INC. NANOSCOPE HANDPIECE 2106165 00888867287839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown