BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASTIPP RESECTOR HANDPIECE

    MDR report key: 23835549 · Received December 17, 2025

    Report

    Report Number
    1220948-2025-00220
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 17, 2025
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663110148
    PMA / PMN Number
    K212894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. MANUFACTURING ATTEMPTED TO RECREATE THE ISSUED WHILE TESTING, BUT WAS UNABLE TO REPRODUCE THE FAILURE FOR 3 DIFFERENT LOTS OF FINISHED GOODS. IT IS LIKELY THAT THE ISSUE IS DUE TO THE USE/SETUP AT THE SITE. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCTION AND TRACEABILITY RECORD FOR THE DEVICE WAS REVIEWED; NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL QUALITY CONTROL TESTS WERE COMPLETED SUCCESSFULLY AND MET SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD ENTERED PHASTIPP RESECTOR HANDPIECE DURING A PHLEBECTOMY PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. IT WAS NOTICED AFTER THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618444 PHASTIPP RESECTOR HANDPIECE RESECTOR HANDPIECE DWQ LEMAITRE VASCULAR, INC. PTR1006 00840663110148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown