BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR P90 ELECTRODE

    MDR report key: 1970010 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00010
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 10, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 F/U 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 VAPR P90 ELECTRODE BROKE OFF INTO THE JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR P90 ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULATING GEI DEPUY MITEK 227204 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK