BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC BIOPSY SYSTEM

    MDR report key: 2683407 · Received October 19, 2007

    Report

    Report Number
    3003862400-2008-00001
    Event Type
    Other
    Date Received
    October 19, 2007
    Date of Event
    August 27, 2007
    Report Date
    October 18, 2007
    Manufacturer
    HOLOGIC, INC - SUROS DIV
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SUROS SALES REP SPOKE WITH THE ACCOUNT REP FROM THE FACILITY AND REPORTED THAT THEY WERE HAVING A PROBLEM WITH A HANDPIECE THAT WAS DIFFICULT TO REMOVE FROM THE PT. ACCOUNT REP REPORTED SPOOLING PRIOR TO REMOVAL OF HANDPIECE FROM THE PT. USER FACILITY ALSO FILED MDR (SEE (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC BIOPSY SYSTEM VACUUM ASSISTED CORE BIOPSY DEVICE KNW HOLOGIC, INC - SUROS DIV ATEC 0909-20 707058

    Patients

    Seq Age Sex Outcome Treatment
    1