BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3042143 · Received March 28, 2013

    Report

    Report Number
    3042143
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF BLADE BROKE IN SINUS CAVITY. ALL PARTS RETRIEVED. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOSCOPIC SINUS SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127807 * BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA MEDTRONIC XOMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR STRAIGHT SHOT MICRODEBRIDER