BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW ARTHROSCOPY FLUID MANAGEMENT DEV

    MDR report key: 23301844 · Received October 15, 2025

    Report

    Report Number
    1220246-2025-04613
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    May 7, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039377
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, H3, H6.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPDATE AVOE 09-OCT-2025 AVOE. A USER REPORT WAS PROVIDED BY THE AUTHORITY FOR THIS CASE. THERE WAS A SIGNIFICANT WATER LEAKAGE FROM THE ARTHROPUMP SYSTEM. THE LEAK WAS DETECTED IN THE TUBING INSIDE THE ROLLER PUMP. VIDEO COLUMN DISPLAYED ¿FLOODED,¿ REQUIRING EMERGENCY SHUTDOWN DUE TO ELECTRICAL HAZARDS AS ALL POWER CABLES WERE SUBMERGED IN SALINE SOLUTION. THE PATIENT WAS NOT AFFECTED, BUT AN EMERGENCY SHUTDOWN AND THE DISCONNECTION OF THE ARTHROSCOPY COLUMN'S ELECTRICAL SYSTEM WAS REQUIRED FOLLOWING A DRYING OF EACH MODULE OF THE COLUMN AND ITS POWER CABLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THERE WAS A LEAK DETECTED IN THE PIPE INSIDE THE ROLLER PUMP. PER THE COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. UPDATE AVOE 09-OCT-2025 AVOE IT WAS CONFIRMED THAT THE ARTHREX PUMP AR-6480 WAS USED WITH THE INITIALLY REPORTED TUBING. THE SN OF THE DEVICE IS (B)(6), SINCE THE CUSTOMER HAS TWO PUMPS AND THEIR USE IS NOT TRACKED. THIS IS THE FIRST TIME SUCH AN INCIDENT HAS OCCURRED, EVEN THOUGH IT IS A DEVICE THAT IS USED VERY OFTEN. THE PROBLEM OCCURRED AS SOON AS IT WAS CONNECTED. NO SIMILAR INCIDENTS SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259583 DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV UNK 00888867039377

    Patients

    Seq Age Sex Outcome Treatment
    1