BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCUCLEAR PRECISION BIPOLAR

    MDR report key: 3955646 · Received July 18, 2014

    Report

    Report Number
    1718850-2014-00233
    Event Type
    Other
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE UPPER JAW OF A VASCUCLEAR PRECISION BIPOLAR BROKE BUT DID NOT COMPLETELY SEPARATE DURING A VEIN HARVESTING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE UPPER JAW OF A VASCULAR PRECISION BIPOLAR BROKE DURING A VEIN HARVESTING PROCEDURE. THE JAW DID NOT COMPLETELY BREAK OFF. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423245 VASCUCLEAR PRECISION BIPOLAR ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI SORIN GROUP USA, INC. NA 1410500057

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR