BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 14241068 · Received April 28, 2022

    Report

    Report Number
    1045254-2022-00219
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    October 28, 2021
    Report Date
    April 28, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUALLY, THE INNER SHAFT WAS BROKEN APPROXIMATELY 0.54 INCHES FROM THE DISTAL END OF THE INNER HUB. THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE INNER HUB. THE OUTSIDE DIAMETER OF THE INNER HUB SHOULD BE 0.330 ± 0.002 INCHES AND MEASURED 0.329 INCHES IN THE UNDAMAGED AREA AND UP TO 0.349 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT DUE TO PHYSICAL DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED WITH NO COMMENT/ALLEGATION OF MALFUNCTION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114855 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK BUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown