BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442657 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00012
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 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 PEDIATRIC CASE, THE ADENOID TIP SEPARATED FROM THE GRAY GROMMET. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA 32662

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR NOT AVAILABLE