BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER XSTAR

    MDR report key: 15671442 · Received October 25, 2022

    Report

    Report Number
    1211998-2022-00105
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 8, 2022
    Report Date
    April 8, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THAT THEY RECEIVED 61 (SLIT KNIFE 2.4MM ANGD SNGL BEV W/SAFETY) WITH SAFETY SHIELDS RETRACTED. ALL WITH THE SAME CATALOG NUMBER WITH 55 WITH LOT NUMBER 6052017 AND 6 WITH LOT NUMBER 6052661. THE RETRACTED SLEEVES WERE DISCOVERED PRIOR TO SURGERY AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509175 BEAVER XSTAR SLIT KNIFE 2.4MM ANGD SNGL BEV W/SAFETY HNN BEAVER-VISITEC INTERNATIONAL, INC. 6052017 AND 6052661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown