BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3909945 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00094
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    February 16, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR FLOWCHART COMPLETED - NOT REPORTABLE. PER SERVICE RECORD #(B)(4) - "UNIT PRIMED AND FUNCTIONED WITHIN ALL SPECIFICATIONS. ADMINISTRATIVE TUBING APPEARS TO BE ALTERED. SCRAP HANDPIECE." COMPLAINT CLOSED; AS OF THIS DATE, THERE ARE (B)(4) DOCUMENTED COMPLAINTS, THE COMPLAINT RATE IS (B)(4). ON 02/04/2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT 19812-03 WAS REVIEWED. THE UNIT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THIS LOT HAS A (B)(4) COMPLAINT RATE. THERE WERE (B)(4) UNITS RELEASED TO DISTRIBUTION. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE A TOTAL OF (B)(4) UNITS THAT STOPPED WORKING AND (B)(4) UNITS WOULD NOT PRIME. FAILURE POSSIBLY DUE TO A BROKEN ELECTRODE. REFER TO CAPA (B)(4). A REVIEW OF THE CONSOLE HISTORY WAS NOT PERFORMED BECAUSE THE CONSOLE SERIAL NUMBER WAS NOT REPORTED WITH THE COMPLAINT

    Description of Event or Problem · 1

    ERROR: DID NOT PRIME. SAID THAT THE FLOW WAS OBSTRUCTED; HOWEVER, FLUID WAS FLOWING FREELY (FLUID AT THE TIP/TUBE AND BAG). AFTER SEVERAL RETRIES INCLUDING REPRIMING AND TURNING IT OFF/ON PRIME FAILED. CHANGED UNIT AND NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114418 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 19812-13

    Patients

    Seq Age Sex Outcome Treatment
    1