BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUT/COAGULATION HANDPIECE FOR OPEN SURGERY

    MDR report key: 3371580 · Received September 6, 2013

    Report

    Report Number
    3004754983-2013-00001
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    Manufacturer
    PLASMA SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K121977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INVESTIGATION OF THE DEVICE AT PLASMA SURGICAL, INC. (COMPLETED ON (B)(4) 2013) INDICATES THAT THERE HAD BEEN AN INGRESS OF LIQUID FROM THE BACK OF THE HANDPIECE HANDLE. THIS WAS DETERMINED DURING A VISUAL EXAMINATION OF THE INTERNAL HANDPIECE COMPONENTS THAT REVEALED A WHITE RESIDUE COATING THE PRINTED CIRCUIT BOARD (PCB). THE INGRESS OF THE LIQUID CAUSED AN ELECTRICAL SHORT OF THE PCB, RESULTING IN THE ACTIVATION OF THE HANDPIECE.

    Description of Event or Problem · 1

    APPROXIMATELY 3 HOURS INTO A PROCEDURE, THE SURGICAL TEAM REPORTS THAT THE HANDPIECE BEGAN IGNITING TO THE SETTINGS SHOWN ON THE CONSOLE ON IT'S OWN. THE STAFF WAS IMMEDIATELY ALERTED THAT THE HANDPIECE WAS FIRING DUE TO THE AUDIBLE ALERT THAT SOUNDS TO INDICATE THAT THE HANDPIECE IS ACTIVE. IN ORDER TO TURN THE HANDPIECE OFF, THE CONSOLE WAS UNPLUGGED. THE SURGICAL TEAM REPORTED THAT THERE WERE NO INJURIES TO PT OR STAFF AND NO MATERIALS IN THE OPERATING ROOM WERE BURNT OR DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444218 CUT/COAGULATION HANDPIECE FOR OPEN SURGERY NONE GEI PLASMA SURGICAL INC. 40076

    Patients

    Seq Age Sex Outcome Treatment
    1