BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW ARTHROSCOPY FLUID MANAGEMENT DEV

    MDR report key: 19511609 · Received June 11, 2024

    Report

    Report Number
    1220246-2024-05568
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    January 2, 2023
    Report Date
    June 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039377
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE IS USER ERROR DUE TO IMPROPER DEVICE SETTINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DOES NOT WORK AS IT SHOULD FOR THE CUSTOMER. THERE IS A PROBLEM WITH THE INFLOW SIDE. WHEN THE CONTAINER WITH THE RINSING LIQUID RUNS EMPTY, THE PUMP STOPS AFTER A MESSAGE, WHICH IS NORMAL. AFTER FILLING THE TANK, THE PUMP SHOULD START RUNNING AGAIN AFTER 2-4 SECONDS. THIS PROCESS TAKES A VERY LONG TIME WITH THE AFFECTED DEVICE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 19-MAY-2023: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SURGERY. UPDATE AVOE 22-MAY-2023: IT WAS CONFIRMED THAT THE SURGERY WAS IN (B)(6). THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078409 DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV 22112019 00888867039377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown