BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATEC PEARL

    MDR report key: 15480784 · Received September 24, 2022

    Report

    Report Number
    1222780-2022-00258
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 25, 2022
    Report Date
    September 23, 2022
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045506855
    PMA / PMN Number
    K042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ATEC PROCEDURE A FOOT PEDAL ISSUE OCCURRED DURING THE PROCEDURE THAT CAUSED THE PHYSICIAN UNABLE TO COLLECT SAMPLES SO THE PATIENT HAD TO BE RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665027 ATEC PEARL INSTRUMENT, BIOPSY KNW HOLOGIC, INC ATEC PEARL 15420045506855

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown