BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 7677107 · Received June 29, 2018

    Report

    Report Number
    7677107
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 11, 2018
    Report Date
    June 21, 2018
    Manufacturer
    HOLOGIC, INC., HEADQUARTERS
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A STEREOTACTIC BREAST BIOPSY, THE HOLOGIC ATEC VACUUM ASSIST MACHINE DID NOT FUNCTION PROPERLY. THIS UNIT DID NOT HAVE THE PROPER AMOUNT OF SUCTION AND WE WERE UNABLE TO GET THE PROPER AMOUNT OF TISSUE RESULTING IN A REPEAT BIOPSY FOR THIS PT. THE PT WENT TO ER LATER THAT EVENING DUE TO SYNCOPE. THE PT DEVELOPED A LARGE 10 CM HEMATOMA AND HER HEMOGLOBIN HAD DROPPED FROM THE BLOOD POOLING IN HER BREAST. WE DID GET THIS VAC ASSIST UNIT REPLACED WITH A REPLACEMENT FROM HOLOGIC. WHEN WE WENT TO DO ANOTHER STEREOTACTIC BIOPSY ON A DIFFERENT PT, THIS REPLACEMENT VAC ASSIST UNIT ALSO LACKED SUCTION AND THIS PT ALSO HAD TO HAVE A REPEAT BIOPSY. HOLOGIC CLINICAL EDUCATOR CAME IN AND SUGGESTED SENDING THIS UNIT BACK FOR ANOTHER REPLACEMENT. THE SECOND PT HAS NOT HAD ANY ISSUES THAT WE ARE AWARE OF AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495784 HOLOGIC ATEC KNW HOLOGIC, INC., HEADQUARTERS SAPPHIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR