BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2120462 · Received May 27, 2011

    Report

    Report Number
    1718850-2011-00041
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 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

    THE DEVICE WAS RETURNED WITH THE JAWS SLIGHTLY OPENED. THE JAWS WOULD NOT COMPLETELY OPEN OR CLOSE AND THE BLADE HAD LIMITED MOVEMENT. THE VISUAL INSPECTION FOUND EVIDENCE OF THE BIPOLAR JAW DAMAGED WAS DUE TO EXCESSIVE TORQUE APPLIED DURING CLAMPING. THE TIP OF THE BIPOLAR WAS INTACT AND HAD NOT BROKEN OFF. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THE TIP OF THE BIPOLAR BROKE OFF INSIDE OF THE PATIENT'S LEG. ALL PARTS WERE RECOVERED. 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