BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2549044 · Received April 18, 2012

    Report

    Report Number
    3007069406-2012-00088
    Event Type
    Other
    Date Received
    April 18, 2012
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. INSPECTION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ANOMALIES DURING THE MFG OF THE LOT. NO PT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC SHEATH ON THE EXT BLADE FRAYED DURING A LAMINECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE EXT 36901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOT AVAILABLE