BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR ELECTRODE

    MDR report key: 1963388 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00014
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 REP IS REPORTING TO US THAT A PT UNDERWENT A SUCCESSFUL WRIST PROCEDURE AROUND (B)(6) 2010 WITH THE USE OF AN UNK VAPR WEDGE ELECTRODE. DURING THIS PROCEDURE, A PORTION OF THE DISTAL TIP OF THE ELECTRODE BROKE OFF AND LODGED IN THE SOFT TISSUE. ON (B)(6) 2010, THE PT UNDERWENT A RE-SURGERY TO REMOVE THE FRAGMENT. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY. THIS IS ALL OF THE INFO PROVIDED TO DATE; THERE FURTHER INFO AND DETAILS TO COME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULAT GEI DEPUY MITEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention