BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS STRAIGHTSHOT M4 MICRODEBRIDER

    MDR report key: 2268084 · Received September 28, 2011

    Report

    Report Number
    1045254-2011-00073
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    August 30, 2011
    Report Date
    December 21, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) IS K041413. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER GUIDE WARNS THAT USE OF A BUR WITHOUT IRRIGATION MAY CAUSE AN INORDINATE AMOUNT OF HEAT BUILDUP RESULTING IN THERMAL INJURY TO TISSUE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF AN OSTEOMA FROM THE FRONTAL SINUS VIA A LOTHROP PROCEDURE. THE SURGEON USED A MICRODEBRIDER WITH THE 55 DEGREE DRILL ATTACHMENT AND HELD THE DRILL SHAFT RATHER THAN THE HANDLE OF THE MICRODEBRIDER. THE DEVICE WAS USED AT 12000 RPMS IN FORWARD DIRECTION. THINGS WERE GOING WELL UNTIL THE PHYSICIAN FELT THE DRILL HEAT UP. THE PHYSICIAN STOPPED IMMEDIATELY. IT WAS REPORTED THAT THE FLUID BAG AND IRRIGATION HAD RUN OUT. THE PATIENT RECEIVED A 1ST DEGREE BURN TO HER UPPER LIP, JUST BELOW THE NOSTRIL. THE PATIENT WAS TREATED WITH ANTIBIOTIC CREAM FOR THE BURN (SILVADENE). THE PATIENT IS CURRENTLY DOING FINE. REPORTEDLY, THE PATIENT RECEIVED A SUPERFICIAL BURN THAT SHOULD HOPEFULLY HEAL WITHOUT A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPS STRAIGHTSHOT M4 MICRODEBRIDER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention (B)(4)