BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1516920 · Received October 16, 2009

    Report

    Report Number
    1718850-2009-00056
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 18, 2009
    Report Date
    September 18, 2009
    Manufacturer
    SORIN GROUP USA
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED WHEN THIS INFORMATION IS AVAILABLE. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV15 KIT. THE CARDIAC CHARGE NURSE REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF INSIDE OF THE PATIENT. THE TIP WAS RECOVERED. THERE WAS NO REPORT OF PATIENT INJURY. THE VISUAL INSPECTION OF THE RETURNED BIPOLAR CONFIRMED THAT THE TIP OF THE JAW WAS INDEED BROKEN OFF. THE BIPOLAR DEVICE WAS SUPPLIED BY AN OUTSIDE VENDOR. THE PRODUCT WAS RETURNED TO THEM FOR FURTHER ANALYSIS. THEY HAVE RESPONDED THAT VISUAL INSPECTION CONFIRMED THAT THE DEVICE JAW WAS BROKEN FROM THE TIP TO THE TOP OF THE JAW. VISUALLY THE BREAK IS A CLEAN BREAK. THE DEVICE CONTINUITY WAS TESTED AND THERE WAS NO ELECTRICAL DEFECTS DETECTED. DRIED BLOOD AND FLUIDS WAS NOTED BETWEEN THE CLOSURE TUBES. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ABNORMALITIES. THE DEVICE MET SPECIFICATIONS. THE VENDOR STATED THAT THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED PRIOR TO PACKAGING. THEY CONCLUDED THAT THE DEVICE WAS DAMAGED DURING USE. THEY HAVE PERFORMED TESTING AND HAVE NOT BEEN ABLE TO DUPLICATE THIS FAILURE MODE. THE BIPOLAR INSTRUCTIONS FOR USE STATE "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT".

    Description of Event or Problem · 1

    THE CARDIAC CHARGE NURSE REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF. THE TIP WAS RECOVERED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1