BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR INSERT CEV625H DIA 5MM FENESTRAT [MXI/XOM]

    MDR report key: 3080784 · Received April 26, 2013

    Report

    Report Number
    6000027-2013-00003
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH INDICATION OF AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PRECLUDE A SERIOUS INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION REPORT NOTED THE INSERT WAS BENT AND THE COATING WAS DAMAGED. ONE OF THE CERAMIC PIECES WAS BROKEN AND THE OTHER WAS CRACKED. IT WAS ALSO NOTED THAT THE INSTRUMENT WAS RETURNED WITHOUT THE PROVIDED PROTECTION. THE INSERT WAS PROBABLY DAMAGED DURING USE OR REPROCESSING BY SHOCKS BECAUSE OF THE LACK OF USE OF PROTECTION PROVIDED, AS ADVISED IN THE INSTRUCTIONS FOR USE (IFU). MOREOVER, THE CRACKS OBSERVED ON THE CERAMIC PINS OF THE DEVICE AND IN THE RECORDING OF THE SURGERY, SHOULD HAVE BEEN DETECTED DURING INSPECTION PRIOR TO USE AS ALSO ADVISED IN THE IFU. THE INSTRUMENT WAS REPLACED UNDER WARRANTY AND BASED ON INVESTIGATION RESULTS, IT WAS REASONABLY CONCLUDED THAT THIS EVENT IS IMPUTABLE TO ABNORMAL OR OFF-LABEL USE BY THE CUSTOMER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY IN THE FORM OF MEDIA, WHICH CONTAINED THE ENTIRE RECORDED SURGERY. IT WAS OBSERVED IN THE RECORDING THAT THE CERAMIC PIN OF THE INSTRUMENT WAS DAMAGED AND PROGRESSIVELY DETACHED DURING SURGERY, UNTIL THE FRAGMENT FELL INTO THE PATIENT BODY. THE FRAGMENT WAS RECOVERED IMMEDIATELY BY THE SURGEON, RESULTING IN NO PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT WAS NOT RETURNED FOR EVALUATION. NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE BEING USED IN A PROCEDURE, THE BIPOLAR INSERTER BROKE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182716 BIPOLAR INSERT CEV625H DIA 5MM FENESTRAT [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED, INC. CEV625H 121101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention