BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822367 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00383
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    August 25, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE TONSIL TIP WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED TONSIL TIP NOTED THAT THE TIP WAS TWISTED INSTEAD OF BENT. THE OBSERVED DEFORMED (TWISTED) TONSIL TIP INDICATED THAT TIP WAS EITHER IMPROPERLY MANIPULATED OR IMPROPERLY REMOVED FROM THE SUCTION HANDPIECE DURING USE. IT IS ALSO POSSIBLE THAT THE TONSIL TIP WAS NOT GRIPED AT THE HOUSING RIDGES DURING MANIPULATION AND THIS MIGHT HAVE CAUSED DIFFICULTY IN EXTRACTION AND/OR INSERTION WHEN EXCHANGING BETWEEN THE TONSIL TIP AND ADENOID TIP. THE GRAY HOUSING WAS MISALIGNED WITH THE TONSIL BLADE DUE TO THE COMBINATION OF THE POSSIBLE FAILURE PREVIOUSLY DESCRIBED. THE FAILURE WAS ATTRIBUTED TO HANDLING TECHNIQUE OF THE DEVICE DURING USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON PERFORMING A TONSILLECTOMY ON A PT AND DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE ELECTRODE LOOKED LIKE IT WAS BENT. ALSO, THE END OF THE BLADE WAS NOT ALIGNED WITH THE SHAFT OR SUCTION PORT. ONCE THIS WAS OBSERVED I TOLD THE SURGEON TO WITHDRAW THE ELECTRODE AND HE WAS GIVEN A NEW ONE. THERE WAS NO THERMAL DAMAGE TO THE PTS TISSUE NOTED AND IT WAS NOT A CONCERN TO THE SURGEON OR SCRUB NURSE. THE SAMPLE IS AVAILABLE FOR EVAL; CUSTOMER WOULD LIKE SOME FEEDBACK AS TO WHY THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 29504

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR