BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727884 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00300
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    May 28, 2013
    Report Date
    January 18, 2014
    Manufacturer
    AOI
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED FROM THE FIELD, BUT IT WAS NOT THE ALLEGED COMPLAINT UNIT. REFER TO EVALUATION #(B)(4)-CUSTOMER STATED HANDPIECE WOULD NOT CUT. RECEIVED ONLY PACKAGING FOR PROOF OF A LOT OF INFORMATION. DEVICE WAS NOT RETURNED FOR EVALUATION. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE ISSUE BECAUSE THE UNIT WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. THE DHR FOR LOT 11213-07 WAS REVIEWED. THE UNITS MET MANUFACTURING SPECIFICATION BEFORE RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THERE WER (B)(4) UNITS RELEASED FROM LOT 11213-07. A REVIEW OF LOT HISTORY SHOWED THAT HERE WERE THREE (3) UNITS TOTAL THAT FAILED FOR FUNCTIONALITY. THIS LOT HAS A FAIR RATE OF (B)(4).

    Description of Event or Problem · 1

    PRIMED OK, BUT NO CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54619 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRANSONIC SURGICAL ASPIRATOR LFL AOI 11213-07

    Patients

    Seq Age Sex Outcome Treatment
    1