BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3727652 · Received January 23, 2014

    Report

    Report Number
    2085033-2014-00309
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Report Date
    January 18, 2014
    Manufacturer
    AOI, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONTACTED THE FACILITY AND THE SALES REP FOR THE COMPLAINT PRODUCT. PER CUSTOMER SERVICE, THE ALLEGED COMPLAINT UNIT WILL NOT BE RETURNED FOR EVALUATION. THE REP DOES NOT HAVE THE HANDPIECE AND THE FACILITY NEVER SENT THE UNIT TO LSO FOR DISINFECTION. THIS FACILITY IS NO LONGER DOING BUSINESS WITH TENEX HEALTH. (B)(4) WILL BE VOIDED. REFER TO (B)(4) FOR VOID REASON - PRODUCT NOT COMING BACK TO US. FACILITY NO LONGER DOING BUSINESS WITH TENEX. THEY HAVE GIVEN THEIR REP ALL OF THEIR PRODUCT. THERE IS SOME DISCREPANCY IN WHAT PRODUCT THE REP DOES IN FACT HAVE, AS THEY HAVE NOT BEEN VERY ACCURATE IN ACCOUNTING FOR TRUNKSTOCK. IT IS NOT POSSIBLE TO VERIFY AN ASSIGNABLE CAUSE FOR THE UNIT FAILURE WITHOUT EVALUATING THE ALLEGED COMPLAINT UNIT. INSUFFICIENT INFORMATION FOR A COMPLETE INVESTIGATION. 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 UNIT FAILURES FROM THIS LOT. LOT 11213-07 HAS A FAILURE RATE OF(B)(4).

    Description of Event or Problem · 1

    CASSETTE WOULD NOT CLICK INTO CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54510 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AOI, INC. 11213-07

    Patients

    Seq Age Sex Outcome Treatment
    1