BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSCOPE HANDPIECE

    MDR report key: 19423962 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04352
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    June 17, 2022
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K201134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THIS EVALUATION DETERMINED THAT THE REPORTED EVENT OF "DURING A WRIST ARTHROSCOPY THE VIEW WAS DARK" OCCURRED DUE TO EXTERNAL DAMAGE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A LENS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY THE VIEW WAS DARK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 24-JUN-2022 UPDATE DW. LOT NUMBER OF THE REPORTED DEVICE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098975 NANOSCOPE HANDPIECE LAPAROSCOPE GCJ ARTHREX, INC. NANOSCOPE HANDPIECE 2106171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown