BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR WEDGE ELECTRODE

    MDR report key: 693160 · Received March 24, 2006

    Report

    Report Number
    1221934-2006-00069
    Event Type
    Malfunction
    Date Received
    March 24, 2006
    Date of Event
    March 23, 2006
    Report Date
    March 23, 2006
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SHOULDER PROCEDURE, A PORTION OF THE DISTAL TIP OF 4 VAPR WEDGE ELECTRODES FELL OFF INTO THE PATIENT'S JOINT SPACE.THEY ARE SURE THAT 3 FRAGMENTS WERE RETRIEVED FROM THE BODY AND ARE UNSURE ABOUT THE 4TH FRAGMENT.THE CASE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.[ASSOCIATED WITH 1121934-2006-00066,00067 & 00068]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR WEDGE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING GEI DEPUY MITEK 225203 0512001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN