BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASTIPP RESECTOR HANDPIECE

    MDR report key: 19665995 · Received July 3, 2024

    Report

    Report Number
    1220948-2024-00128
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 3, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    PMA / PMN Number
    K212894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, THE PROVIDED PHOTO CONFIRMED THE REPORT. MANUFACTURING ATTEMPTED TO RECREATE THE ISSUE 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 LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD IS CONTINUOUSLY GETTING TRAPPED IN THE PHASTIPP RECTOR HANDPIECE. THE STAFF HAS BEEN USING PEROXIDE TO CLEAN WITH A Q-TIP. NO INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756102 PHASTIPP RESECTOR HANDPIECE RESECTOR DWQ LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown