BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902316 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00083
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    July 27, 2012
    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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION FLOWCHART COMPLETED - NOT REPORTABLE WITHOUT EVALUATING THE UNIT, THE ACTUAL CAUSE OF THE MALFUNCTION CANNOT BE DETERMINED; A CAUSE OF FAILURE CAN BE DETERMINED BY FAILURES ALREADY SEEN IN-HOUSE FROM MFG OR SERVICING; AS OF THIS DATE, THERE WERE (B)(4) DOCUMENTED DEVICE COMPLAINTS COVERING (B)(4) UNITS. THIS LOT HAS (B)(4) RELEASED UNITS. THE COMPLAINT RATE IS AT (B)(4). THE LOT WILL CONTINUE TO BE MONITORED. NO CAPA WILL BE ISSUED SINCE THE RATE IS ACCEPTABLE ((B)(4)). THIS LOT COULD HAVE POSSIBLY HAD THE BURR ISSUE NO FURTHER INVESTIGATION WAS DONE AND THE COMPLAINT WAS CLOSED BASED ON THE FOLLOWING - CAPA (B)(4) WAS OPENED ON (B)(4)2 012 DUE TO CUSTOMER SERVICE'S CONCERN WITH NUMEROUS MICROTIPS HAVING PROBLEMS IN THE FIELD; IT WAS DETERMINED THAT EARLIER LOTS WERE FAILING DUE TO A BURR ON THE COMPRESSION NUT. ECO 959 WAS GENERATED TO UPDATE THE DWG. THE DHRS FROM ALL LOTS MANUFACTURED SINCE (B)(6) 2012 WERE REVIEWED AND NO CORRELATION COULD BE DETERMINED AMONG SUB-ASSEMBLIES. ON (B)(4) 2014: OPENED CAPA (B)(4) TO REVIEW (B)(6) COMPLAINTS; COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT# 11412-06 WAS REVIEWED. THE UNIT MET MFG 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 THE CONSOLE HISTORY WAS NOT PERFORMED BECAUSE THE S/N WAS NOT REPORTED.

    Description of Event or Problem · 1

    DURING PROCEDURE, TIP STOPPED WORKING - TRIED UNSUCCESSFULLY TO REBOOT SYSTEM, FORCED TO OPEN SECOND KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113503 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 11412-06

    Patients

    Seq Age Sex Outcome Treatment
    1