BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5105513 · Received September 25, 2015

    Report

    Report Number
    1045254-2015-00317
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE BLADE WAS BEING USED IN REVERSE MODE AT 5000 RPM TO REMOVE SOFT TISSUE TUMOR(S). THE ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 22, 2016.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE BLADE WAS BEING USED IN REVERSE MODE AT 5000 RPM TO REMOVE SOFT TISSUE TUMOR(S).

    Description of Event or Problem · 1

    THE AVAILABLE INFORMATION INDICATES THE TIP OF THE BLADE BROKE OFF DURING A SINUS SURGERY. A REPLACEMENT BLADE WAS USED TO COMPLETE THE SURGERY AND A CT SCAN WAS PERFORMED TO CONFIRM THAT NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637008 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209773942

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention