BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL W/SCISSOR

    MDR report key: 1541770 · Received November 3, 2009

    Report

    Report Number
    1718850-2009-00068
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 6, 2009
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 KTV17 KIT. THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE JAW TIP WAS RECOVERED. THERE WAS NO REPORT OF PATIENT INJURY. THE BIPOLAR DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE TIP OF THE UPPER JAW WAS BROKEN OFF. THE MANUFACTURING RECORDS WERE REVIEWED. THE DEVICE MET ALL RAW MATERIALS. IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE. NO ABNORMALITIES WERE NOTED. THE CAUSE FOR THE BROKEN JAW COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED DURING USE. THE INSTRUCTIONS FOR THE 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." THE 100% VISUAL INSPECTION UNDER MAGNIFICATION HAS BEEN IMPLEMENTED IN PRODUCTION TO PROVIDE FURTHER ASSURANCE OF JAW INTEGRITY. THE PROTECTIVE CAP FOR THE JAW HAS ALSO BEEN IMPROVED.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE JAW 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 W/SCISSOR BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 0922300001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR