BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 5419928 · Received February 9, 2016

    Report

    Report Number
    1045254-2016-00036
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    January 17, 2016
    Report Date
    January 17, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESS PROCEDURE "THE TIP OF THE SILVER BULLET BLADE 4.0 MM WAS BROKEN DURING A SURGERY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THE BROKEN PIECES WERE COLLECTED AND NO BROKEN PIECE REMAINED IN THE PATIENT'S BODY." IT WAS FURTHER CONFIRMED THAT "THE FRAGMENT WAS FOUND ON THE CHEST OF PATIENT; IT WAS PICKED UP BY HAND." THERE WERE NO INTERVENTIONS REQUIRED; THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82913 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209789084

    Patients

    Seq Age Sex Outcome Treatment
    1