BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH LONGVIEW W/SCIS

    MDR report key: 1526229 · Received November 9, 2009

    Report

    Report Number
    1718850-2009-00079
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 16, 2009
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER WAS NOT PROVIDED BY THE CLINICIAN. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH LONG KTV23 KIT. ONE BIPOLAR DEVICE WAS REC'D AT SORIN GROUP USA FOR EVAL. THE INSPECTION OF THE RETURNED BIPOLAR CONFIRMED THAT THE TIP OF THE DEVICE WAS BROKEN OFF. THE MFG RECORDS WERE REVIEWED. THE DEVICE MET ALL RAW MATERIALS, IN-PROCESS AND FINISHED GOODS SPECS 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 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". A 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 OPERATING ROOM MANAGER REPORTED THAT THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE JAW TIP BROKE OFF DURING THE PROCEDURE. THE TIP WAS RETRIEVED. THERE WAS NO REPORT OF PT INJURY DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH LONGVIEW W/SCIS BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 0922900040

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR