BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727614 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00303
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    June 4, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RECEIVED FOR EVALUATION. REFER TO EVALUATION (B)(4). RECEIVED UNIT FROM LSO AFTER PROCESSING. TIP AND CASE NOSE WERE BENT UPON RECEIPT. CASE NOSE WAS CRACKED AT TIP OF NEEDLE. APPEARS TO HAVE BEEN DROPPED. WOULD NOT PRIME. FLUID PATH BLOCKED MESSAGE DUE TO POOR FLOW AT THE DAMAGED CASE NOSE AND NEEDLE JUNCTION. ULTRASONIC CUTTING FUNCTION PERFORMED WITHIN ALL SPECIFICATIONS. WITH NEEDLE CAP INSTALLED, DAMAGE TO THE TIP AND CASE NOSE COULD NOT HAVE OCCURRED. APPEARS CUSTOMER DAMAGED HANDPIECE (IE. DROPPED OR IMPROPER TECHNIQUE). THE DHR FOR MICROTIP LOT 12713-03 WAS REVIEWED. THE PART MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    MADE LOW CUTTING NOISE AND THE NEEDLE WAS BENT ONCE REMOVED FROM PATIENT. HANDPIECE SENT TO LSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54463 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 12713-03

    Patients

    Seq Age Sex Outcome Treatment
    1