BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3910098 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00095
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    August 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RETURNED DUE TO PATIENT CONTACT. MDR FLOWCHART CREATED - NOT REPORTABLE. COMPLAINT CLOSED; AS OF THIS DATE, THERE ARE 20 DOCUMENTED COMPLAINTS. THE COMPLAINT RATE IS (B)(4). ON (B)(4) 2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: THE UNIT HAD MADE PATIENT CONTACT AND WAS NOT RECEIVED FOR EVALUATION. IT IS NOT POSSIBLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THIS ISSUE. THERE IS INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT 20212-03 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 8 UNITS THAT STOPPED WORKING. 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

    DURING PROCEDURE, PRIMED PROPERLY, BUT THEN WOULD NOT WORK ON PATIENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114386 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 20212-03

    Patients

    Seq Age Sex Outcome Treatment
    1