BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VAPR ELECTRODE

    MDR report key: 2901221 · Received January 8, 2013

    Report

    Report Number
    1221934-2013-00013
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    July 20, 2010
    Report Date
    January 4, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED FOR VISUAL AND FUNCTIONAL INSPECTION. PRODUCT CODE(S) AND BATCH NUMBER(S) HAVE NOT BEEN PROVIDED TO PRECISELY IDENTIFY THE DEPUY MITEK VAPR ELECTRODE AND THEREFORE A BATCH REVIEW CANNOT BE PERFORMED AT THIS TIME TO DETERMINE IF THERE WERE ANY MANUFACTURING RELATED ISSUES. WHEN AND IF ANY ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REVIEWED AND EVALUATED AND THE DETAILS WILL BE INCLUDED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT SINCE THE INITIAL MEDWATCH REPORT FOR THE ABOVE ISSUE, DEPUY MITEK HAS RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE ABOVE ISSUE HAD BEEN PREVIOUSLY REPORTED. DEPUY MITEK HAD FILED A MEDWATCH REPORT IN 2011 AND THEREFORE ANY ADDITIONAL UPDATES TO THIS EVENT WILL BE ASSOCIATED WITH MANUFACTURERS REPORT NUMBER 12219341-2011-00014.

    Description of Event or Problem · 1

    A PATIENT HAD DEBRIDEMENT OF RIGHT WRIST (TFCC) ON OR ABOUT (B)(6) 2010. SUBSEQUENTLY, A METALLIC OBJECT WAS FOUND IN THE RIGHT WRIST REQUIRING A SECOND SURGERY ON OR ABOUT (B)(6) 2010. THE WORKING TIP WAS ALLEGEDLY A DEPUY MITEK VAPR RF WAND. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9118 UNKNOWN VAPR ELECTRODE VAPR ACCESSORIES GEI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1