BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2623098 · Received June 14, 2012

    Report

    Report Number
    1718850-2012-00678
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT, DURING THE VEIN HARVESTING PROCEDURE, A BLUE PIECE WAS SEEN IN THE PATIENT'S LEG. ATTEMPTS TO RETRIEVE THE PIECE WERE REPORTEDLY UNSUCCESSFUL BUT THERE WAS NO APPARENT EFFECT TO THE PATIENT. THE DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT, DURING THE VEIN HARVESTING PROCEDURE, A BLUE PIECE WAS SEEN IN THE PATIENT'S LEG. THERE WAS NO APPARENT EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SORIN GROUP USA, INC. NA 1200300018

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR