BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR SE ELECTRODE

    MDR report key: 2060869 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00107
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    May 16, 2008
    Report Date
    March 4, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS, AT THIS POINT IN TIME, IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF A MITEK VAPR SE ELECTRODE BROKE OFF INTO THE PT'S JOINT SPACE. THE FRAGMENT WAS RETRIEVED FROM THE BODY. THIS EVENT TOOK PLACE ON (B)(6) 2008; THE FACILITY DID NOT REPORT THIS TO MITEK, BUT DID REPORT IT TO THE (B)(4). OUR AFFILIATE WAS NOTIFIED ON (B)(6) 2011, 34 MONTHS LATER. NO PT INFO WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR SE ELECTRODE ELECTROSURGICAL, CUTTING/COAG GEI DEPUY MITEK 225301 M0710095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK