BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3670155 · Received January 27, 2014

    Report

    Report Number
    2085033-2014-00469
    Event Type
    Malfunction
    Date Received
    January 27, 2014
    Date of Event
    November 21, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "UNIT WAS RECEIVED FROM THE FIELD FOR EVAL. REFER TO EVAL # (B)(4) - VERIFIED REPORTED CRACK IN CASE NOSE. ALSO NOTED A DEFORMATION AT THE TIP OF THE HORN CREATING A SMALL HOOK. BOTH PHYSICAL ATTRIBUTES STRONGLY SUGGEST THE HANDPIECE WAS DROPPED. HANDPIECE WAS DISCARDED AFTER EVAL. THE CAUSE CANNOT BE VERIFIED. THE DHR FROM MICROTIP LOT# 26713-04 WAS REVIEWED AND SHOWED THAT THE UNITS MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    HANDPIECE WAS PRIMED AND STARTED CUTTING. DOCTOR NOTICED SEVERE LEAKING. CRACK IN PLASTIC CASING BELOW NEEDLE. SECOND HANDPIECE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58273 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 26713-04

    Patients

    Seq Age Sex Outcome Treatment
    1