BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECITON DEVICE

    MDR report key: 2442658 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00013
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. ONLY THE ADENOID TIP WAS RETURNED FOR EVALUATION. FAILURE INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THE EVENT REPORT THE BENDABLE SECTION OF THE ADENOID TIP WAS SEPARATED FROM THE FINGER GRIP. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO THE GLUE BOND BETWEEN THE TUBING AND GINGER GRIP. (B)(4) HAS BEEN INITIATED TO ADDRESS TUBING DETACHING FROM THE FINGER GRIP ON ADENOID TIP-ASSEMBLIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE ADENOID BLADE SEPARATED FROM THE PIECE THAT PLUGS INTO THE HANDPIECE. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECITON DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA 30408

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR NOT AVAILABLE