BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, LPR, VD, PB, LS

    MDR report key: 2162268 · Received July 6, 2011

    Report

    Report Number
    1718850-2011-00066
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS REQUESTED. THE FACILITY DID NOT PROVIDE PT INFO. TO DATE, NO PRODUCT HAS BEEN RECEIVED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THEY NOTED BLUE PLASTIC DEBRIS IN THE ENDOSCOPIC CHANNEL. THE WOUND WAS IRRIGATED TO FLUSH OUT THE DEBRIS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, LPR, VD, PB, LS BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1108300065

    Patients

    Seq Age Sex Outcome Treatment
    1