BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BUR GUARD - VISAO®

    MDR report key: 5597949 · Received April 22, 2016

    Report

    Report Number
    1045254-2016-00121
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 22, 2016
    Report Date
    March 29, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K983224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3334800 - DRILL, VISAO 80K HANDPIECE; 510K - K011321. NO SERIAL OR LOT NUMBER WAS PROVIDED; THEREFORE THE MANUFACTURING DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT YET BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE HANDPIECE DID NOT PROPERLY LOCK THE BUR ATTACHMENT INTO PLACE AND THE ATTACHMENT RATTLED. AT SOME POINT IN THE SURGERY, THE TIP OF THE IRRIGATION BUR GUARD BROKE OFF INSIDE THE PATIENT. THE STAFF WAS UNABLE TO LOCATE THE TIP, TOOK X-RAYS OF THE PATIENT, AND DETERMINED THAT THE TIP WAS NOT IN THE PATIENT. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255965 XPS® BUR GUARD - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention