BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2176772 · Received July 15, 2011

    Report

    Report Number
    1718850-2011-00075
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 16, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A COMPLAINT AND MEDWATCH REPORT, (B)(4), REPORTING THAT THE PLASTIC RAIL DISCONNECTED FROM THE RETRACTOR HANDLE DURING USE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. THE CASE WAS COMPLETED WITHOUT THE NEED TO REPLACE THE DEVICE. THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE PLASTIC RAIL WAS SEPARATED FROM THE RETRACTOR AND THAT THE SMALL TABS ON THE DISTAL END OF THE RAIL WHICH CONNECT THE RAIL TO THE SPOON HAD BROKEN OFF. THE FAILURE OF THESE TABS IS BELIEVED TO BE THE CAUSE OF THE DISCONNECTION. INVESTIGATION PERFORMED ON REPRESENTATIVE UNITS FROM INVENTORY FOUND THAT THE FAILURE MODE COULD BE RE-CREATED BY APPLYING SIGNIFICANT TORQUE DIRECTLY TO THE RAIL. TORQUE TESTING PERFORMED ON UNITS FROM INVENTORY FOUND THAT, IN ORDER TO SEPARATE THE RAIL FROM THE DEVICE, A FORCE THREE TIMES THE DEVICE SPECIFICATION MUST BE APPLIED DIRECTLY TO THE PLASTIC RAIL TO SEPARATE IT FROM THE RETRACTOR. ALTHOUGH THE CAUSE OF THE SEPARATION CANNOT BE CONFIRMED, THE TORQUE REQUIRED TO SEPARATE THE RAIL IS WELL ABOVE SPECIFICATION AND THERE IS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. THE VASCULAR RETRACTOR INSTRUCTIONS FOR USE STATE "DO NOT USE EXCESSIVE FORCE". IT IS BELIEVED THAT THE SEPARATION OCCURRED AS A RESULT OF EXCESSIVE TORQUE APPLIED TO THE RAIL DURING USE. NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING THAT THE PLASTIC RAIL DISCONNECTED FROM THE RETRACTOR HANDLE DURING A VEIN HARVESTING PROCEDURE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. THE CASE WAS COMPLETED WITHOUT THE NEED TO REPLACE THE DEVICE.

    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 1108200001

    Patients

    Seq Age Sex Outcome Treatment
    1