BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 1459087 · Received June 29, 2009

    Report

    Report Number
    1718850-2009-00014
    Event Type
    Malfunction
    Date Received
    June 29, 2009
    Date of Event
    May 10, 2009
    Report Date
    May 26, 2009
    Manufacturer
    EVH
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CLINICIAN TO OBTAIN PATIENT INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE PATIENT INFORMATION IF RECEIVED. THIS ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WAS MANUFACTURED BY DATASCOPE CORPORATION LOCATED IN (B)(4). SORIN GROUP USA HAS SINCE ACQUIRED THIS PRODUCT LINE. SORIN GROUP USA IS FILING THIS REPORT ON BEHALF OF DATASCOPE. ONE BIPOLAR DEVICE WAS RECEIVED AT SORIN GROUP USA FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE TIP OF THE JAW WAS BROKEN OFF. THE DATASCOPE MANUFACTURING RECORDS DID NOT REVEAL ANY ABNORMALITIES. DATASCOPE'S VENDOR OF THE BIPOLAR DEVICE HAS BEEN MADE AWARE OF THIS ISSUE. FURTHER INVESTIGATION IS UNDERWAY. A FOLLOW-UP REPORT WILL BE FILED WHEN INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 1

    THE CLINICIAN INITIALLY REPORTED THAT THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE MALFUNCTIONED DURING THE PROCEDURE, BUT THE DEVICE JAW DID NOT BREAK OFF. RETURNED PRODUCT DID DEMONSTRATE THAT A PIECE OF THE JAW TIP WAS MISSING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH SMALL BIPOLAR DEVICE GEI EVH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1