BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822324 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00388
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 08/15/2010 THROUGH 08/15/2012. VISUAL INSPECTION REVEALED NO ANOMALIES WITH THE RETURNED DEVICE. FUNCTIONAL TESTING COULD NOT REPLICATE THE EVENT REPORTED. THE CUT AND COAG BUTTONS ACTIVATED UPON PRESSING. THE ROOT CAUSE COULD NOT BE DETERMINED. REVIEW OF THE LOT HISTORY RECORD REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON FINISHED WITH THE ADENOIDS, WHEN THE SCRUB TECH. WAS TRYING TO CLEAN SOME CHAR OFF OF THE WIRE, THE WIRE BROKE. I GOT THE TIP AFTER THE CASE AND IT WAS INDEED BROKEN. IT IS UNCERTAIN IF IT HAPPENED DURING THE CASE OR DURING CLEANING. THE SURGEON THOUGHT IT MAY HAVE HAPPENED DURING CLEANING. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 30959

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR