BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLE AND KNIFE,DULL TIP

    MDR report key: 1976143 · Received February 1, 2011

    Report

    Report Number
    1045254-2011-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    KTG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTS THAT NO FURTHER INVESTIGATION WILL OCCUR AT THIS TIME. HOWEVER, IT WILL CONTINUE TO MONITOR THE RATE AND PATTERN OF OCCURRENCE, AND MAY RE-OPEN THE FILE AS APPROPRIATE. THE MEDTRONIC (B)(4) OFFICE IS ATTEMPTING TO RETRIEVE THE INSTRUMENT FOR ANALYSIS. IF THE INSTRUMENT IS RETURNED, ADDITIONAL INFORMATION WILL BE SUBMITTED ON A SUPPLEMENTAL MDR. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR ANY DELAY IN THE SURGICAL PROCEDURE. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER. THE REPORTED PRODUCT IS BEING USED FOR TREATMENT AND NOT FOR DIAGNOSIS. IF ANY ADDITIONAL INFORMATION IS MADE AVAILABLE OR WHEN THE PRODUCT IS RETURNED FOR ANALYSIS, A SUPPLEMENTAL 3500A WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTS THAT NO FURTHER INVESTIGATION WILL OCCUR AT THIS TIME. HOWEVER IT WILL CONTINUE TO MONITOR THE RATE AND PATTERN OF OCCURRENCE, AND MAY RE-OPEN THE FILE AS APPROPRIATE. THE MEDTRONIC (B)(4) OFFICE IS ATTEMPTING TO RETRIEVE THE INSTRUMENT FOR ANALYSIS. IF THE INSTRUMENT IS RETURNED, ADDITIONAL INFORMATION WILL BE SUBMITTED ON A SUPPLEMENTAL MDR. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR ANY DELAY IN THE SURGICAL PROCEDURE. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER. THE REPORTED ITEM THIS PRODUCT BEING USED FOR TREATMENT AND NOT FOR DIAGNOSIS IF ANY ADDITIONAL INFORMATION IS MADE AVAILABLE OR WHEN THE PRODUCT IS RETURNED FOR ANALYSIS A SUPPLEMENTAL 3500A WILL BE FILED. MDR 1045254-2011-00007 WAS SUBMITTED ON (B)(4) 2011, AND THE FOLLOWING IS A SUPPLEMENTAL TO THAT REPORT. THE INSTRUMENT WAS RETURNED ON (B)(4) 2011. A VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED THE TIP WAS BROKEN OFF APPROXIMATELY 8.32 MM FROM THE TIP. A MAGNIFIED VIEW OF THE BROKEN SECTIONS OF THE TIP REVEALED A CHIP HAD BEEN BROKEN OUT OF THE BLADE. ALSO NOTED WERE DENTS AND NOTCHES ALONG THE BLADE EDGE. THIS WOULD INDICATE THE TIP WAS DAMAGED PRIOR TO THE REPORTED BREAK.

    Description of Event or Problem · 1

    THIS REPORT WAS FORWARDED FROM (B)(6) THE (B)(4) FACILITY. THE REPORT INDICATES AT THE BEGINNING OF AN ENDOSCOPIC SINUS PROCEDURE, THE INSTRUMENT TIP FRACTURED IN THE PATIENT'S SINUS. THE SURGEON RETRIEVED THE TIP FROM THE SINUS AS SOON AS IT HAPPENED, WITHOUT THE NEED FOR ADDITIONAL SURGICAL PROCEDURES OR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLE AND KNIFE,DULL TIP KTG MEDTRONIC XOMED INC. 3714244 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR