BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HD SPECIMEN RADIOGRAPHY

    MDR report key: 22534782 · Received July 17, 2025

    Report

    Report Number
    3005496266-2025-00032
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 17, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    MWP
    PMA / PMN Number
    K182727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025, THAT DURING A TRIDENT HD SPECIMEN RADIOGRAPHY SYSTEM PROCEDURE, THE USER OBSERVED DETECTOR ERRORS ON THE SYSTEM. IT IS REPORTED THAT DUE TO THE TRIDENT DETECTOR ERROR, THE USER HAD TO UTILIZE A PORTABLE X-RAY SYSTEM TO CONFIRM THAT THE MAG SEED AND CLIP HAD BEEN REMOVED IN THE BREAST TISSUE. HOWEVER, THE X-RAY SYSTEM IMAGES WERE NOT CLEAR ENOUGH TO CONFIRM REMOVAL OF THE MAG SEED AND CLIP; THEREFORE, OUT OF CAUTION, THE USER REMOVED MORE BREAST TISSUE FROM THE PATIENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE EQUIPMENT AND CONFIRMED THE DETECTOR ERRORS. THE FSE CHECKED ALL ELECTRICAL CONNECTIONS, REPLACED THE DC BOARD AND AN ADDITIONAL BOARD FOR THE DETECTOR. THE FSE THEN MADE TEST IMAGES, VERIFIED SYSTEM FUNCTIONALITY AND CONFIRMED THAT THE UNIT IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. ONCE THE TRIDENT WAS RETURNED TO THE USER, THE USER REPORTS THAT THE PATIENT'S IMAGE WAS UPLOADED TO THE IMAGE VIEWER AND THE USER WAS ABLE TO SEE BOTH THE MAG SEED AND CLIP IN THE ORIGINAL X-RAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764562 TRIDENT HD SPECIMEN RADIOGRAPHY CABINET, X-RAY SYSTEM MWP HOLOGIC, INC TRI-00002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other