BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATEC INTRODUCER LOCALIZATION SET SURESIGHT

    MDR report key: 4902330 · Received July 1, 2015

    Report

    Report Number
    1222780-2015-00121
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    HOLOGIC
    Product Code
    GDF
    PMA / PMN Number
    K022921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2015. "WHEN THE PHYSICIAN REMOVED THE SECOND OBTURATOR THE CLEAR PIECE OF IT CAME OFF AND REMAINED IN THE PATIENT'S BREAST". THE CLEAR PIECE REMAINED INSIDE THE PATIENT AS THE PATIENT WAS GOING TO HAVE SURGERY SOON AFTER THE BIOPSY PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429721 ATEC INTRODUCER LOCALIZATION SET SURESIGHT GDF HOLOGIC 0914-20-OB 412575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ATEC HANDPIECE - LOT NUMBER UNK