BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2392319 · Received December 15, 2011

    Report

    Report Number
    1718850-2011-00241
    Event Type
    Other
    Date Received
    December 15, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 15, 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
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING A VEIN HARVESTING PROCEDURE, THE OPTICAL VESSEL DISSECTOR CAME APART INSIDE OF THE PT. ALL PIECES OF THE PRODUCT WERE RETRIEVED. THERE WAS NO REPORT OF PT INJURY. SORIN GROUP HAS REQUESTED THE PRODUCT BE RETURNED FOR EVAL. TO DATE, NO PRODUCT HAS BEEN RECEIVED. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING A VEIN HARVESTING PROCEDURE, THE OPTICAL VESSEL DISSECTOR CAME APART INSIDE OF THE PT. ALL PIECES OF THE PRODUCT WERE RETRIEVED. THERE WAS NO REPORT OF PT INJURY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR