BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 3769128 · Received December 30, 2013

    Report

    Report Number
    2085033-2013-00167
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 29, 2013
    Manufacturer
    AOI, INC
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS RETURNED FOR EVALUATION. COULD NOT VERIFY THE MALFUNCTION. THE UNIT PRIMED SUCCESSFULLY. DURING THE EXECUTION OF PROTOCOL NUMBER P12-0048, IRRIGATION DID NOT SHUT OFF AFTER PROLONGED USAGE. IT WAS DETERMINED THAT THE VACUUM SENSOR DIAPHRAGM MOVEMENT IS BEING RESTRICTED, WHICH PREVENTS A COMPLETE RELEASE OF VACUUM CAUSING THE REFLUX VALVE TO REMAIN OPEN. TO CORRECT THE PROBLEM, THE SPACER VALVES WERE MANUFACTURED ON THE HIGHER END OF THEIR SPECIFICATION TO ENSURE CONTACT OF THE HANDPIECE CARTRIDGE WITH THE CONSOLE AND AN ELLIPTICAL FEATURE WAS ADDED TO THE CASSETTE TO ALLOW FOR THE SENSOR TO MOVE MORE FREELY. UNITS THAT WERE RETURNED THROUGH THE COMPLAINT SYSTEM WERE SERVICED AND THE SPACER VALVES WERE REPLACED PER CAPA (B)(4). THERE HAVE BEEN NO OTHER REPORTED ISSUES CONCERNING THIS CONSOLE. WHAT APPEARS TO BE FLUID BUILDUP, ONLY SEEMS TO OCCUR DURING AN ELBOW PROCEDURE DUE TO THE SKIN BEING TIGHT IN THIS REGION. THE COMPANY'S CHIEF MEDICAL OFFICER HAS DOCUMENTED THAT THERE IS NO HARM TO THE PATIENT WITH THE EXCESS FLUID. THE BODY WILL ABSORB IT. THERE HAVE BEEN NO REPORTED EVENTS OF FLUID RETENTION SINCE (B)(6) 2012. DOCTORS WITH MORE CASES TEND TO SQUEEZE OUT EXCESS FLUID AS PART OF THEIR ROUTINE. A PRODUCT RECALL WAS INITIATED MAY 2013 TO REPLACE SPACER VALVES ON CONSOLES IN DISTRIBUTION.

    Description of Event or Problem · 1

    SURGEON SAID A LOT OF FLUID REMAINED IN THE JOINT LEAVING A TENNIS BALL SIZE BUMP ON THE PATIENT'S ELBOW. THE SURGEON THEN PUSHED THE REMAINING AMOUNT OF FLUID OUT OF THE PATIENT'S ELBOW. HE ASKED THAT WE SEND THE CONSOLE BACK TO CHECK FOR ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681421 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR MGI LFL AOI, INC

    Patients

    Seq Age Sex Outcome Treatment
    1