BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE PRECIS BIPOLAR

    MDR report key: 1459063 · Received June 26, 2009

    Report

    Report Number
    1718850-2009-00015
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    May 22, 2009
    Report Date
    May 28, 2009
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WAS MANUFACTURED BY DATASCOPE CORPORATION (B) (4). SORIN GROUP USA HAS SINCE ACQUIRED THIS PRODUCT LINE. SORIN GROUP USA IS FILING THIS REPORT ON BEHALF OF DATASCOPE. THE BIPOLAR DEVICE IS BEING RETURNED FOR EVAL, BUT HAS NOT YET BEEN RECEIVED AT SORIN GROUP USA. THE DATASCOPE MANUFACTURING RECORDS FOR THE BIPOLAR PACK DID NOT REVEAL ANY ABNORMALITIES. DATASCOPE'S VENDOR OF THE BIPOLAR DEVICE HAD BEEN MADE AWARE OF THIS ISSUE. FURTHER INVESTIGATION IS UNDERWAY. A FOLLOW-UP REPORT WILL BE FILED WHEN INFO IS MADE AVAILABLE AND THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE INCIDENT OCCURRED AFTER THE PROCEDURE AND THEREFORE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE PRECIS BIPOLAR BIPOLAR DEVICE GEI DATASCOPE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1