BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BUR

    MDR report key: 4940296 · Received July 24, 2015

    Report

    Report Number
    1045254-2015-00253
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 29, 2015
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE RETURN WAS REQUESTED BUT HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ¿A BUR BROKE DURING A TRANSPHENOIDAL PROCEDURE LAST TUESDAY AND THEY NEVER RETRIEVED IT. THEY APPARENTLY XRAYED THE PATIENTS. AND COULDN'T FIND IT. PATIENT IS OKAY.¿ ADDITIONALLY, A (B)(4) WAS RECEIVED, REPORTING ¿DRILL BIT TIP (BURR) BROKE OFF DURING CASE. IT WAS UNABLE TO BE LOCATED. SKULL X-RAYS TAKEN WERE NEGATIVE. NO PATIENT HARM IDENTIFIED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481960 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1883673HS 0209556178

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR