BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFERIOR TURBINATE BLADE

    MDR report key: 2181772 · Received July 27, 2011

    Report

    Report Number
    1045254-2011-00054
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON RECEIPT FROM THE CUSTOMER IT WAS NOTED DURING VISUAL INSPECTION BY (B)(4) QUALITY ENGINEER THAT THE MIDDLE BLADE TIP OF THE MIDDLE SHAFT WAS MISSING. THE MISSING BLADE TIP FRAGMENT WAS NOT SEEN IN RETURNED PACKAGE. NO ROOT CAUSE FOR THE PRODUCT MALFUNCTION CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 DURING A SEPTOPLASTY, TURBINATE REDUCTION AND FUNCTIONAL ENDOSCOPIC SINUS (FESS) PROCEDURE, A PIECE OF METAL WITHIN THE INTERNAL STRUCTURE OF THE BLADE BROKE OFF WHILE IN USE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENT WITHOUT INJURING THE PATIENT, OR NEED FOR ADDITIONAL INTERVENTION OR TREATMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SEQUELA REPORTED. NO ADDITIONAL FOLLOW-UP CARE AS A RESULT OF THIS EVENT WAS REPORTED. POWERED SHAVERS ARE INTENDED FOR THE INCISION AND REMOVAL OF SOFT AND HARD TISSUE OR BONE IN GENERAL OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY. SINUS INDICATIONS INCLUDE SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, AND FRONTAL SINUS DRILL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFERIOR TURBINATE BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC 1882940HR H7798069

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR