BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1547644 · Received November 24, 2009

    Report

    Report Number
    1718850-2009-00088
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    October 29, 2009
    Report Date
    October 29, 2009
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. THEREFORE, PT INFO IS NOT APPLICABLE. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV15 KIT. DURING AN EVALUATION OF A PRODUCT COMPLAINT FOR ANOTHER ISSUE, A PRECISION BIPOLAR DEVICE WAS SENT TO A SUPPLIER FOR ADDITIONAL EVALUATION. THE JAW OF THE DEVICE BROKE DURING TRANSPORT TO THE SUPPLIER. ALTHOUGH STANDARD DEVICE PACKAGING WAS NOT IN USE, A DECISION WAS MADE TO REPORT THIS FAILURE. TESTING HAS SHOWN THAT THE MATERIAL USED IN THE PLASTIC PROTECTIVE CAP MAY WEAKEN THE PRECISION BIPOLAR UPPER JAW AND CAUSED IT TO BREAK. A NEW PROTECTIVE CAP HAS BEEN IMPLEMENTED TO ELIMINATE THIS POSSIBILITY. A FIELD ACTION HAS BEEN INITIATED ALERTING ALL CUSTOMER OF THE ISSUE AND PROVIDING INSTRUCTIONS OF THE SAFE USE AND RETURN OF PRODUCT. A FOLLOW-UP REPORT WILL BE FILED ONCE A FIELD ACTION (Z) NUMBER IS ASSIGNED BY THE FDA DISTRICT OFFICE.

    Description of Event or Problem · 1

    DURING AN EVALUATION OF A PRODUCT COMPLAINT FOR ANOTHER ISSUE, A PRECISION BIPOLAR DEVICE WAS SENT TO A SUPPLIER FOR ADDITIONAL EVALUATION. THE JAW OF THE DEVICE BROKE DURING TRANSPORT TO THE SUPPLIER. ALTHOUGH STANDARD DEVICE PACKAGING WAS NOT IN USE, A DECISION WAS MADE TO REPORT THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH SMALL BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 0921500031

    Patients

    Seq Age Sex Outcome Treatment
    1