BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3664186 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00363
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    August 5, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. REFER TO EVALUATION # (B)(4) OPENED UNITS RETURNED. CUSTOMER STATED " "FAILED PRIMING." " FOUND BOTH CASSETTES WITH MISALIGNED PERISTALTIC TUBING AND SIGNS OF DISTRESS ON THE TUBING WALLS. WITH TUBING ALIGNED PROPERLY, BOTH CASSETTES PRIMED PROPERLY. ATTRIBUTE FAILURES TO TRAINING. THE DHR FOR LOT 11213-07 WAS REVIEWED. THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WERE (B)(4) UNITS RELEASED FROM LOT 11213-07. THERE WERE (B)(4) REPORTED MICROTIP UNIT FAILURES FROM THIS LOT. LOT 11213-07 HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    MICROTIP WOULD NOT PRIME. THREE ATTEMPTS WERE MADE TO PRIME. EACH TIME I WENT THROUGH THE SET UP PROCESS STEP-BY-STEP AND THE CASSETTE CLICKED AND TUBING WAS CHECKED TO MAKE SURE THEY WERE ALL IN THE CORRECT GROOVES. I OPENED ANOTHER MICROTIP AND REPEATED THE SAME PROCESS FOUR TIMES WITHOUT PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54889 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR MGI LFL AMERICAN OPTISURGICAL, INC. 11213-07

    Patients

    Seq Age Sex Outcome Treatment
    1