BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1604633 · Received February 12, 2010

    Report

    Report Number
    1718850-2010-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Report Date
    January 15, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    Z-0624-0630-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN REPORTED THAT DURING THE PROCEDURE, THE TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THERE WAS NO REPORT OF PT INJURY. ONE BIPOLAR WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TIP WAS BROKEN OFF. TESTING HAS SHOWN THAT THE MATERIAL USED IN THE PLASTIC PROTECTIVE CAP MAY WEAKEN THE PRECISION BIPOLAR UPPER JAW AND CAUSE IT TO BREAK. A NEW PROTECTIVE CAP HAS BEEN IMPLEMENTED TO ELIMINATE THIS POSSIBILITY. A FIELD ACTION HAS BEEN INITIATED ALERTING ALL CUSTOMERS OF THE ISSUE AND PROVIDING INSTRUCTIONS ON THE SAFE USE AND RETURN OF PRODUCT. THIS DEVICE AND LOT NUMBER WAS NOT ORIGINALLY REPORTED BY THE CLINICIAN BUT WAS RETURNED ON JAN 15, 2010 WITH PRODUCT ASSOCIATED WITH ANOTHER MEDWATCH REPORT, REF 1718850-2009-000173. THIS LOT NUMBER WAS INCLUDED IN THE RECALL.

    Description of Event or Problem · 1

    THE CLINICAL REPORTED THAT DURING THE PROCEDURE, THE TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE PIECE WAS RETRIEVED FROM THE PT. THERE WAS NO REPORT OF THE PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH SMALL BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 0924300023

    Patients

    Seq Age Sex Outcome Treatment
    1