BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAUGHAN SOFT TISSUE PUNCH

    MDR report key: 2241831 · Received September 9, 2011

    Report

    Report Number
    9680837-2011-00011
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT IS BREAKING DURING USE AND THE MUSHROOM END IS REPORTEDLY FALLING OFF INTO THE SPHENOID SINUS. THE USER FACILITY REPORTED APPROXIMATELY EIGHT SIMILAR INCIDENTS BREAKING WITHIN THE LAST TWELVE MONTHS BUT NO DETAILS WERE PROVIDED. IT IS UNKNOWN WHETHER ALL EIGHT OF THE TIPS FELL INTO THE SPHENOID SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAUGHAN SOFT TISSUE PUNCH INSTRUMENT, ENT MANUAL SURGICAL LRC MEDTRONIC XOMED INSTRUMENTATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1