BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2625767 · Received June 13, 2012

    Report

    Report Number
    3007069406-2012-00113
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    June 26, 2011
    Report Date
    June 6, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT AVAILABLE FOR EVALUATION BECAUSE THE DEVICE HAD BEEN DISCARDED. A REVIEW OF THE LHR DID NOT REVEAL ANY ISSUES DURING THE MANUFACTURING OF THIS LOT. SUBJECT THAT PARTICIPATED IN PEAK TONSILLECTOMY STUDY REPORT POST-OP BLEED NINE DAYS AFTER POST-OPERATIVELY. SUBJECT WAS ADMITTED TO OPERATING ROOM FOR PHYSICIAN TO CONTROL THE BLEEDING. PER THE PHYSICIAN, SUBJECT WAS PLAYING BASEBALL AND THIS STRENUOUS ACTIVITY CAUSED THE BLEEDING. IT WAS NOT DUE TO THE DEVICE.

    Description of Event or Problem · 1

    PT REPORTED POST-OP BLEED 9 DAYS AFTER TONSILLECTOMY. BLEED OCCURRED AFTER PT WAS PLAYING BASEBALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 31254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NOT AVAILABLE