BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR SE ELECTRODE

    MDR report key: 1153115 · Received September 8, 2008

    Report

    Report Number
    1221934-2008-00428
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 2, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MITEK FOR FAILURE ANALYSIS. IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY WITH THE VAPR ELECTRODE, THE PT RECEIVED BURNS AROUND THE ENTRANCE TO THE CANNULA AND DOWN THE ARM. BURNS AROUND THE CANNULA RESULTED IN LOSS OF SURFACE SKIN. BURNS LOOK TO BE THE RESULT OF OVER-HEATED FLUID FROM THE JOINT. A PLASTIC SURGEON WAS CONSULTED AND PT RECEIVED BURN GEL. THIS TYPE OF FAILURE INDICATES THAT THIS WAS A USER ISSUE, A CASE OF INADEQUATE FLUID MANAGEMENT WHICH HAS BEEN IDENTIFIED AS THE PRECIPITATOR FOR THESE TYPES OF ADVERSE EVENTS. WE ATTRIBUTE THE ISSUE TO TECHNIQUE. NO FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY WITH THE VAPR ELECTRODE, THE PT RECEIVED BURNS AROUND THE ENTRANCE TO THE CANNULA AND DOWN THE ARM. BURNS AROUND THE CANNULA RESULTED IN LOSS OF SURFACE SKIN. BURNS LOOK TO BE THE RESULT OF OVER-HEATED FLUID FROM THE JOINT. A PLASTIC SURGEON WAS CONSULTED AND PT RECEIVED BURN GEL. THE CASE WAS COMPLETED USING A SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR SE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING GEI DEPUY MITEK 225301 0802002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other