BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2428903 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00024
    Event Type
    Other
    Date Received
    January 20, 2012
    Date of Event
    April 11, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. THE FACILITY DID NOT RETAIN THE DEVICE FOR EVAL, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT NUMBER WAS NOT PROVIDED SO A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. TONSIL BLEED: "ONE SIDE WENT VERY WELL. THE SECOND SIDE COULDN'T GET HEMOSTASIS." SURGEON USED A SUCTION BOVIE TO CONTROL BLEEDING AND IT APPEARED TO BE UNDER CONTROL. ONCE THE PT WAS EXTUBATED, THE BLEEDING STARTED AGAIN. SURGEON WASN'T SURE IF IT WAS A ROUGH WAKE UP BY ANESTHESIA OR THE PRODUCT.

    Description of Event or Problem · 1

    INITIAL EVENT DESCRIPTION: PT HAD BLEEDING DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NOT AVAILABLE