BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2162299 · Received July 8, 2011

    Report

    Report Number
    1718850-2011-00073
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A SMALL SCRATCH IN THE UPPER JAW OF THE DEVICE, INDICATING THAT SOME MATERIAL HAD WORN AWAY ON ONE SIDE. DIMENSIONAL ANALYSIS OF THE RETURNED UNIT FOUND THAT THE JAW GUIDE WAS OUT OF SPECIFICATION, WHICH IS INDICATIVE OF AN EXCESSIVE AMOUNT OF TISSUE BEING CLAMPED INTO THE JAW. THE DAMAGE IS CONSISTENT WITH HAVING BEEN CAUSED BY CONTACT BETWEEN THE METAL JAW GUIDE AND INNER SHAFT. 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. 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," AND "EXCESSIVE TISSUE ACCUMULATED WITHIN THE JAWS MAY PREVENT KNIFE BLADE FROM FULLY RETURNING TO ITS NEUTRAL POSITION." 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 INVESTIGATE THE POTENTIAL FOR DAMAGE TO THE BIPOLAR WHEN EXCESSIVE FORCE IS APPLIED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE,THE CUSTOMER NOTED BLUE PLASTIC DEBRIS IN THE ENDOSCOPIC CHANNEL. SALINE SOLUTION WAS USED TO FLUSH THE DEBRIS OUT OF THE WOUND. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1