BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23717237 · Received December 4, 2025

    Report

    Report Number
    8043817-2025-00011
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426090204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEWED MANUFACTURING RECORDS, PROCESS CONTROLS, AND COMPLAINT TRENDS. NO SAMPLE OR PHOTOS WERE RETURNED; DEFECT COULD NOT BE REPRODUCED. LOT HISTORY SHOWED COMPLIANCE WITH SPECIFICATIONS AND NO DEVIATIONS. NO MATERIAL, EQUIPMENT, OR ENVIRONMENTAL ISSUES IDENTIFIED. RISK ASSESSMENT: OVERALL RISK LEVEL LOW. ROOT CAUSE UNDETERMINED; POSSIBLE USER HANDLING FACTORS CANNOT BE EXCLUDED. NO CORRECTIVE ACTION OR FIELD SAFETY NOTICE REQUIRED; EVENT WILL BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LUMPECTOMY WITH SENTINEL LYMPH NODE BIOPSY, THE PROTECTIVE STERILE PROBE COVER WAS FOUND TO HAVE A BREACH AT THE TIP AFTER THE PROCEDURE. BLOOD WAS OBSERVED ON THE UNDERLYING PROBE, WHICH IS NOT STERILIZABLE AND IS INTENDED TO REMAIN ISOLATED FROM TISSUE CONTACT. THE BREACH COMPROMISED THE STERILE BARRIER AND POSED A POTENTIAL INFECTION RISK. THE AFFECTED COVER WAS DISCARDED, AND A REPLACEMENT STERILE COVER WAS APPLIED. NO PATIENT HARM OCCURRED, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978411 MEDLINE-MICROTEK GENERAL PURPOSE PROBE COVER PUI MICROTEK MEDICAL LLC GPC396EU 00748426090204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown