BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW ARTHROSCOPY FLUID MANAGEMENT DEV

    MDR report key: 18419806 · Received December 29, 2023

    Report

    Report Number
    1220246-2023-09778
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    March 15, 2022
    Report Date
    December 29, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039377
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS NOT CONFIRMED. THE SERVICE EVALUATION REVEALED DAMAGES AT THE FRONT PANEL ALONG WITH A WORN OUTFLOW MOTOR BUT THERE WAS NO ISSUE WITH THE PRESSURE OBSERVED DURING FUNCTIONAL TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ISSUE WITH THE PRESSURE WAS IDENTIFIED. AN ARTHREX REPRESENTATIVE WAS ON SIDE BUT WAS NOT ABLE TO RESOLVE THE ISSUE WITH A REPLACEMENT OF THE TUBING SET. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE SWIT (B)(6) 2022. THE PUMP SHOWED PRESSURE FAULT BEFORE STARTING THE OPERATION. BY SWITCHING THE PUMP OFF/ ON A FEW TIMES THE PRESSURE FAULT INDICATION WAS GONE. BUT IT CAME BACK DURING THE OPERATION. THEY COULD HELP THEM BY SWITCHING AGAIN THE PUMP OFF/ON. ALSO, THE TUBING WAS CHANGED DURING THE OPERATION, BUT THE INDICATION CAME AGAIN ¿PRESSURE FAULT ¿, ALARM AND PUMP STOPPED. THEY HAD NEVER THE GOOD PRESSURE DURING THE OPERATION LIKE BEFORE. UPDATE DW (B)(6) 2022. THE SURGEON, DR. (B)(6), WAS ABLE TO FINISH THE ROTATOR CUFF SURGERY SUCCESSFULLY WITH OUR ARTHROSCOPIC DEVICES. 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
    1666038 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 Unknown