BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1510884 · Received October 14, 2009

    Report

    Report Number
    1718850-2009-00073
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    September 14, 2009
    Report Date
    September 14, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV15 KIT. THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE DURING CLEANING. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY. ONE BIPOLAR DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION CONFIRMED THAT THE TIP WAS BROKEN. AFTER INSPECTION AT SORIN GROUP USA, THE DEVICE WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE EVALUATION IS COMPLETE. 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 CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WHILE CLEANING IT. THE INCIDENT OCCURRED DURING CLEANING. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT AND NO 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