BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2660737 · Received July 12, 2012

    Report

    Report Number
    3007069406-2012-00117
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 16, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ADENOID PLASTIC TIP MELTED DURING SURGERY. PRIOR TO THE PLASTIC MELTING, A "LIGHT SPARK" WAS OBSERVED THROUGH THE ENDOSCOPIC CAMERA SYSTEM. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADENOID PLASTIC TIP MELTED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 49299

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOT AVAILABLE