BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP, LS

    MDR report key: 2466748 · Received February 17, 2012

    Report

    Report Number
    1718850-2012-00015
    Event Type
    Other
    Date Received
    February 17, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 19, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE JAW OF THE BIPOLAR BROKE TOWARD THE END OF THE PROCEDURE BUT STAYED ATTACHED TO THE DEVICE. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT. THE BIPOLAR WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE LOWER JAW WAS BROKEN OFF. THE PIECE WHICH HAD BROKEN OFF WAS NOT RETURNED. CLOSER INSPECTION REVEALED THAT THE MATERIAL JUST PROXIMAL TO THE FRACTURE IS CURVED AWAY FROM THE UPPER JAW. TESTING PERFORMED ON REPRESENTATIVE UNITS FROM INVENTORY FOUND THAT THE FAILURE MODE COULD BE RECREATED BY FORCIBLY BENDING THE LOWER JAW DIRECTLY AWAY FROM THE UPPER JAW. BASED ON THE ABOVE, IT HAS BEEN DETERMINED THAT THE BREAKAGE WAS MOST LIKELY CAUSED BY THE LOWER JAW BEING BENT AWAY FROM THE UPPER JAW WITH SIGNIFICANT FORCE. THE VASCUCLEAR INSTRUCTIONS FOR USE STATE, "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT." IN ADDITION, THE INSTRUCTIONS FOR USE STATE "EXAMINE THE DEVICE CAREFULLY PRIOR TO USE, DURING USE AND AFTER COMPLETING THE PROCEDURE TO ENSURE THE JAW IS INTACT. IF THE JAW IS NOT INTACT, LOCATE MISSING PIECES. DO NOT USE THE DEVICE IF DAMAGED." NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE JAW OF THE BIPOLAR BROKE TOWARD THE END OF THE PROCEDURE BUT STAYED ATTACHED TO THE DEVICE. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP, LS ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI SORIN GROUP USA, INC. NA 1130400026

    Patients

    Seq Age Sex Outcome Treatment
    1