BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1510432 · Received October 2, 2009

    Report

    Report Number
    1718850-2009-00042
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 3, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA HAS REQUESTED PT INFO FROM THE PHYSICIAN'S ASSISTANT. A FOLLOW-UP REPORT WILL BE FILED WHEN THIS INFO IS AVAILABLE. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV15 KIT. SORIN GROUP USA RECEIVED A REPORT THAT THE TIP OF THE BIPOLAR DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED WITHOUT ISSUE. THERE WAS NO REPORT OF PT INJURY. THE DEVICE WILL BE RETURNED TO SORIN GROUP USA FOR EVAL. UPON RECEIPT, A FOLLOW-UP REPORT WILL BE FILED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE PHYSICIANS ASSISTANT REPORTED THAT DURING THE PROCEDURE, THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE TIP WAS RETRIEVED. IT WAS REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THE INCIDENT.

    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