BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAXITRON CORE

    MDR report key: 12345520 · Received August 19, 2021

    Report

    Report Number
    1220984-2021-00029
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 19, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MWP
    UDI-DI
    00857069006005
    PMA / PMN Number
    K082432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE. THIS IS A RESUBMISSION OF THE REPORT SUBMITTED ON 07/30/2021 SUBMITTED UNDER : 1222780-2021-00217 TO CORRECT THE MANUFACTURER REGISTRATION NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON JULY 14TH DURING AN IMAGING PROCEDURE FOR A SAMPLE, THE SPECIMEN FELL OFF THE DRAWER AND INTO THE MACHINE. THE STAFF WEREN´T ABLE TO RETRIEVE THE SAMPLE AND THE PATIENT HAD TO BE RESCHEDULED FOR A NEW TISSUE ACQUISITIONS PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240460 FAXITRON CORE CABINET, X-RAY SYSTEM MWP HOLOGIC, INC. COREVISION 5X10 00857069006005

    Patients

    Seq Age Sex Outcome Treatment
    1