BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727913 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00327
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    July 10, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROTIPS WERE NOT AVAILABLE FOR EVALUATION. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNITS. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 11613-06 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 11613-06. THERE WERE (B)(4) REPORTED UNIT FAILURES FROM THIS LOT. THIS LOT HAS A FAILURE RATE OF (B)(4).

    Description of Event or Problem · 1

    TWO SEPARATE MICROTIPS FAILED TO PRIME DURING SET UP PRIOR TO PROCEDURE. THIRD HAND PIECE PRIMED SUCCESSFULLY. REP WAS NOT PRESENT AT THE CASE. REP WAS NOTIFIED THE MORNING AFTER THE CASE. CUSTOMER DID NOT MICROTIPS TO RETURN. PLEASE SHIP REPLACEMENT MICRO TIPS ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55073 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 11613-06

    Patients

    Seq Age Sex Outcome Treatment
    1