BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR HOOK ELECTRODE

    MDR report key: 2062281 · Received March 18, 2011

    Report

    Report Number
    1221934-2011-00120
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION 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 USE THAT DURING AN ARTHROSCOPIC KNEE REPAIR, A PORTION OF THE DISTAL TIP OF A VAPR HOOK ELECTRODE BROKE OFF INTO THE PT'S BODY. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR HOOK ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK 227305 M1007046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK