BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRATED 4MM BLADE 1884002 5PK

    MDR report key: 1781199 · Received July 29, 2010

    Report

    Report Number
    1045254-2010-00033
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    March 15, 2010
    Report Date
    June 29, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT 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, DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THERE WAS NO PATIENT IMPACT AND NO ADDITIONAL FOLLOW UP CARE WAS REQUIRED AS A RESULT OF THIS EVENT. THE REPORTED LOT WAS MANUFACTURED WITH NO NON-CONFORMANCES AND NO ANOMALIES. NO PRODUCT WAS RETURNED AND NO RESERVE SAMPLES OF THE LOT ARE AVAILABLE FOR EVALUATION. A REVIEW OF THE COMPLAINT HISTORY INDICATES NO TRENDS FOR THIS PRODUCT. INSTRUCTIONS FOR USE STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: EXCESSIVE PRESSURE APPLIED TO BLADE MAY CAUSE BLADE FRACTURE. SHOULD A BLADE FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BLADE ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNRESOLVED BLADE FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC SINUS SURGERY, A 5MM PORTION OF THE BLADE TIP BROKE OFF AND WAS EASILY REMOVED FROM THE PATIENT WITH NO DELAY OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERRATED 4MM BLADE 1884002 5PK 77EQJ EQJ MEDTRONIC XOMED, INC. 1884002 35520100

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR