BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SHR, VD, BP

    MDR report key: 2143123 · Received June 17, 2011

    Report

    Report Number
    1718850-2011-00061
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 18, 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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP USA RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THEY NOTED DEBRIS IN THE WOUND. SALINE SOLUTION WAS USED TO FLUSH THE DEBRIS OUT OF THE WOUND. THE BIPOLAR DEVICE WAS USED FOR THE ENTIRE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS DUE TO THE EVENT. EVALUATION OF THE RETURNED DEVICE FOUND SIGNS OF WEAR ON THE UPPER JAW AND BENDING OF THE METAL JAW GUIDE. THESE OBSERVATIONS SUGGEST THAT THE ISSUE WAS CAUSED BY MISUSE INCLUDING AN EXCESSIVE AMOUNT OF TISSUE HAVING BEEN CLAMPED IN THE JAWS AND/OR EXCESSIVE TORQUE APPLIED DURING USE. THE VASCUCLEAR BIPOLAR INSTRUCTIONS FOR USE CONTAINS WARNINGS INTENDED TO ADDRESS THE MISUSE. SORIN GROUP HAS COMPLETED A FORMAL CAPA INVESTIGATION WITH THE PURPOSE OF REDUCING THE POTENTIAL FOR DAMAGE TO THE BIPOLAR WHEN EXCESSIVE FORCE IS APPLIED. THE CAPA INVESTIGATION RESULTED IN THE IMPLEMENTATION OF A DESIGN IMPROVEMENT AND AN UPDATE TO THE INSTRUCTIONS FOR USE INTENDED TO REDUCE THE POTENTIAL FOR DAMAGE UNDER SUCH MISUSE. A REVIEW OF COMPLAINT DATA OVER THE PERIOD SINCE THESE CHANGES WERE IMPLEMENTED HAS DETERMINED THAT THE CHANGES WERE EFFECTIVE. NO FURTHER ACTION IS DEEMED NECESSARY.

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THEY NOTED DEBRIS IN THE WOUND. SALINE SOLUTION WAS USED TO FLUSH THE DEBRIS OUT OF THE WOUND. THE BIPOLAR DEVICE WAS USED FOR THE ENTIRE PROCEDURE. THERE WERE NO PT COMPLICATIONS DUE TO THE EVENT. THE PRODUCT WAS RETURNED FOR EVAL. THE VISUAL INSPECTION FOUND THAT THE UPPER JAW WAS WORN ON BOTH SIDES. THE METAL GUIDE WAS BENT UPWARD. THE ANALYSIS OF THE BIPOLAR DEVICE INDICATES THAT THE PROBLEM EXPERIENCED BY THE CLINICIAN WAS CAUSED BY APPLYING EXCESSIVE TORQUE DURING CLAMPING AS A RESULT OF TOO MUCH TISSUE IN THE JAWS. ANY OF THESE ACTIONS COULD HAVE RESULTED IN THE JAW TO TORQUE TOWARDS THE METAL GUIDE, CAUSING THE MATERIAL TO SCRAPE OFF AND BEND THE GUIDE. A CAPA HAS BEEN ISSUED TO REDUCE THE POTENTIAL FOR DAMAGE TO THE BIPOLAR WHEN EXCESSIVE FORCE IS APPLIED.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THEY NOTED DEBRIS IN THE WOUND. SALINE SOLUTION WAS USED TO FLUSH THE DEBRIS OUT OF THE WOUND. THE BIPOLAR DEVICE WAS USED FOR THE ENTIRE PROCEDURE. THERE WERE NO PT COMPLICATIONS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18184 VC EVH, OD, SHR, VD, BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1109400124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown