BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS SYSTEM NAVIGATED BLADE

    MDR report key: 11640286 · Received April 9, 2021

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    Report

    Report Number
    9612501-2021-00564
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    EQJ
    UDI-DI
    00763000034023
    PMA / PMN Number
    K130608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE CHATTERED DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH IMAGE GUIDANCE PROCEDURE. THE BLADES WAS BEING USED ON THE PATIENT WHEN IT CHATTERED. THEY CHANGED THE HANDPIECE AND CONSOLE AND STILL IT CHATTERED. THEY CHANGED TO A NEW BLADE WITH A DIFFERENT LOT NUMBER AND NO CHATTERING OCCURRED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538955 XPS SYSTEM NAVIGATED BLADE BUR, EAR, NOSE AND THROAT EQJ COVIDIEN LLC 1884380EM 0221182518 00763000034023

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR