BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS BLADE

    MDR report key: 11901206 · Received May 28, 2021

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    Report

    Report Number
    9612501-2021-00867
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 28, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    EQJ
    UDI-DI
    00763000038168
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS WOBBLY DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE PROCEDURE WAS COMPLETED BY A BACK UP DEVICE WITH 5 MINUTES DELAY. THE DEVICE HAD IN CONTACT WITH THE PATIENT. THERE WAS NO TROUBLESHOOTING DONE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799135 XPS BLADE BUR, EAR, NOSE AND THROAT EQJ COVIDIEN LLC 1884380HR 0221618125 00763000038168

    Patients

    Seq Age Sex Outcome Treatment
    1