BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442659 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00014
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. THE PROBLEM WAS THE AREA LOCATED BETWEEN THE BLADE AND THE SUCTION PORT, A FILMS OF CLEAR PLASTIC THAT HAD PEELED ABOUT 3/4 BACK FROM THE ACTIVE BLADE AND THE GREY SUCTION PORTAL AREA. THE BLADE REMAINED FULLY INTACT. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE WHEN THE PHYSICIAN TOUCHED THE AREA AFTER RELEASING THE CUT BUTTON, HE BURNED HIS FINGER/FELT HEAT THROUGH THE GLOVE. 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 3.0S 32665

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE