BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1510881 · Received October 14, 2009

    Report

    Report Number
    1718850-2009-00049
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    September 11, 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

    PATIENT INFORMATION WAS REQUESTED. THE CLINICIAN STATED THAT THIS INFORMATION WAS NOT AVAILABLE. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV15 KIT. THE BIPOLAR DEVICE WAS DISCARDED BY THE CLINICIAN AND IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE PHYSICAL DEVICE, THE CAUSE FOR THE REPORTED BREAK CANNOT BE DETERMINED. THE TRACEABILITY OF THE DEVICE CANNOT BE IDENTIFIED AND THEREFORE, THE MANUFACTURING RECORDS CAN NOT BE REVIEWED. 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 DURING THE PROCEDURE, THE JAW BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE PIECE WAS RETRIEVED FROM THE PATIENT. 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 NP