BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLOGIC - LORAD-

    MDR report key: 1894008 · Received November 2, 2010

    Report

    Report Number
    MW5018060
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 2, 2010
    Manufacturer
    HOLOGIC
    Product Code
    IZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMALE OUT-PT PRESENTS FOR A RIGHT BREAST STEREOTACTIC CORE BIOPSY UTILIZING A HOLOGIC-LORAD- MULTICARE PLATINUM STEROTACTIC BREAST BIOPSY X-RAY UNIT. THE DAILY QA WAS PERFORMED BY A MAMMOGRAPHY TECHNOLOGIST AND THE QA PASSED. WHEN THE PT WAS UNDERGOING THE RIGHT BREAST BIOPSY SYSTEM FAILED TO TARGET CORRECT ON 2 DIFFERENT BIOPSY ATTEMPTS AS THE SYSTEM WAS UNABLE TO OBTAIN AN X-COORDINATE ON THE IMAGE. SYSTEM WAS TAKEN OUT OF USE AND HOLOGIC SERVICE WAS CALLED. THE SERVICE ENGINEER FROM HOLOGIC FOUND PADDLE SET SCREWS THAT BECAME LOOSE CAUSING THE REFERENCE HOLE TO BE MIS-ALIGNED WHICH CAUSED THE FAILED RIGHT BREAST BIOPSY X2. DATES OF USE: (B)(6) 2005 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: BREAST BIOPSY OF ABNORMAL LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC - LORAD- MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other