BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 1884075HSE 15CM X 4MM 15DEG CUTTING

    MDR report key: 2604496 · Received June 8, 2012

    Report

    Report Number
    1045254-2012-00332
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 10, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FINAL REVIEW FOR COMPLETION, IT WAS NOTED THAT THE AWARE DATE WAS REPORTED INCORRECTLY. THE CORRECT AWARE DATE IS (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    UPON FINAL REVIEW FOR COMPLETION, IT WAS NOTED THAT THE AWARE DATE WAS REPORTED INCORRECTLY. THE CORRECT ORIGINAL AWARE DATE IS (B)(4) 2012. THIS WAS NOTED ON 09/14/2012.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. CONCLUSION: WAS ENTERED TO FACILITATE EMDR SUBMISSION. (B)(4). THE INFORMATION REASONABLY SUGGESTS THAT THE 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. WITH NO REPORTED INJURY AND LACK OF INFORMATION THIS EVENT IS BEING FILED AS AN ADVERSE EVENT/ PRODUCT PROBLEM. DEVICE DESCRIPTION - THE STRAIGHTSHOT MICRODEBRIDER SYSTEM IS DESIGNED TO ACCOMMODATE A NUMBER OF OTORHINOLARYNGOLOGY PROCEDURES, INCLUDING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), ADENOIDECTOMY, REMOVAL OF LARYNGEAL AND VOCAL CORD LESIONS, RHINOPLASTY, DERMABRASION, AND SUBMENTAL LIPECTOMY. A VARIETY OF DISPOSABLE BLADES AND BURS ARE AVAILABLE FOR THIS PURPOSE. THESE DISPOSABLES ARE FOR USE WITH ALL STRAIGHTSHOT AND MAGNUM MICRODEBRIDER HANDPIECES. BLADE AND BUR ACCESSORIES ARE AVAILABLE FOR RESECTION OF SOFT TISSUE AND BONE FOR SURGICAL PROCEDURES. USE OF ACCESSORIES DEPENDS ON THE INTENDED APPLICATION AND PATIENT NEEDS. SHARP-CUTTING POWERED ACCESSORIES INDUCE BLEEDING AND REMOVAL OF SIGNIFICANT TISSUE AND BONE. EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. BUR FRAGMENTS THAT ARE NOT REMOVED MAY CAUSE TISSUE DAMAGE TO THE PATIENT. 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

    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 SCHEDULED SKULL BASE SURGERY THE SURGEON BROKE 9 BURS. "A MAJORITY OF THE BREAKS OCCURRED WITH THE NECK COMPLETELY SNAPPING OFF, WITH THE DRILL BIT GETTING STUCK IN THE PATIENT'S SINUS. I WOULD THEN HAVE TO RETRIEVE IT WITH A FORCEPS. OTHER TIMES IT WOULD MAKE A SOUND, THEN SPUTTER, AND SPIN ONLY PARTIALLY." THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1884075HSE 15CM X 4MM 15DEG CUTTING BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1884075HSE NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) 70DEGREE DIAMOND BUR X3