BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822313 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00431
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    August 25, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED OF THE ADENOID TIP REVEALED THE ELECTRODE WIRE WAS BROKEN AND THE CLEAR HOUSING HAD SLIGHT MELT BACK. THE LOCATION OF THE ELECTRODE WERE BRAKE WAS AT THE CORNER OF THE HOUSING. EXCESSIVE CLEANING DURING USE CONTRIBUTED TO THE WIRE BREAKAGE. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ADENOID BLADE BROKE. IT MAY HAVE BEEN DUE TO SCRUB TECH CLEANING. THERE WERE NO PATIENT CONSEQUENCES. SECOND OF 3 EVENTS; SEE 3007069406-2012-00430 AND 3007069406-2012-00432.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 46645

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR