BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2303780 · Received October 7, 2011

    Report

    Report Number
    1718850-2011-00208
    Event Type
    Other
    Date Received
    October 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 8, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TIP OF THE BIPOLAR DEVICE BROKE OFF IN THE PT'S LEG DURING A VEIN HARVESTING PROCEDURE. THE TIP WAS RETRIEVED. THE FACILITY REPORTED THAT THE PT WAS FINE. THERE WAS NO HARM TO THE PT AS A RESULT OF THIS INCIDENT. THE FACILITY STATED THAT THE BIPOLAR DEVICE WAS NOT SAVED FOR EVAL. WITHOUT AN EVAL OF THE DEVICES INVOLVED, NO ROOT CAUSE FOR THE REPORTED FAILURE CAN BE DETERMINED. THE INSTRUCTIONS FOR USE STATE "TO ENSURE THAT THE INSTRUMENT WILL CLOSE PROPERLY, DO NOT INSERT TOO MUCH TISSUE IN THE JAWS", "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT" NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TIP OF THE BIPOLAR DEVICE BROKE OFF IN THE PT'S LEG DURING A VEIN HARVESTING PROCEDURE. THE TIP WAS RETRIEVED. THERE WAS NO REPORT OF HARM TO THE PT AS A RESULT OF THIS INCIDENT. IT WAS REPORTED THAT THE PT IS FINE.

    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 1117400005

    Patients

    Seq Age Sex Outcome Treatment
    1