BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASUCLEAR PRECISION BIPOLAR

    MDR report key: 2822889 · Received October 24, 2012

    Report

    Report Number
    1718850-2012-01023
    Event Type
    Other
    Date Received
    October 24, 2012
    Date of Event
    July 29, 2012
    Report Date
    September 27, 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
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA REC'D A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE THE UPPER TIP OF THE BIPOLAR BROKE OFF INSIDE THE PT'S LEG. THE CLINICIAN RECOVERED THE PIECE FROM THE PT'S LEG. THERE WAS NO PT INJURY. THE BIPOLAR DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVAL. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA REC'D A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE THE UPPER TIP OF THE BIPOLAR BROKE OFF INSIDE THE PT'S LEG. THE CLINICIAN RECOVERED THE PIECE FROM THE PT'S LEG. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASUCLEAR PRECISION BIPOLAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SORIN GROUP USA, INC. NA 1208600089

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR