BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2120482 · Received May 27, 2011

    Report

    Report Number
    1718850-2011-00048
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 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
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL. NO PRODUCT HAS BEEN RECEIVED TO DATE. 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 A PIECE OF DEBRIS WAS NOTED IN THE ENDOSCOPIC CHANNEL. THE DEBRIS WAS REMOVED AND DISCARDED. THE CLINICIAN CONTINUED TO USE THE INSTRUMENTS FOR THE VEIN HARVESTING PROCEDURE. THERE WERE NO PT COMPLICATIONS DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1108200001

    Patients

    Seq Age Sex Outcome Treatment
    1