BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 2457566 · Received February 16, 2012

    Report

    Report Number
    1045254-2012-00021
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 25, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER THE DEVICE IN QUESTION, OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED SINCE INITIAL DISTRIBUTION. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. A POWERED HANDPIECE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY USES A VARIETY OF DISPOSABLE BLADES AND BURS. THE INDICATIONS FOR USE OF BURS AND BLADES IN SINUS INDICATIONS INCLUDE: SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, MAXILLARY SINUS POLYPECTOMY, CIRCUMFERENTIAL MAXILLARY ANTROSTOMY, AND CHOANAL ATRESIA. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO SELECT THE APPROPRIATE INSTRUMENT FOR EACH CASE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SINUS SURGERY, THE BUR BROKE IN THE FRONTAL SINUS AND THE SURGERY WAS EXTENDED. THE PATIENT WAS FINE POST SURGERY. NO PATIENT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1883672HS NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention