BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-USE CUT/COAG HANDPIECE FOR OPEN SURGERY

    MDR report key: 4092092 · Received August 21, 2014

    Report

    Report Number
    3004754983-2014-00001
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 19, 2014
    Manufacturer
    PLASMA SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K080197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORATION ADDRESSED BY OPERATOR AT THE TIME OF EVENT. NO REPORTED ADVERSE IMPACT ON PATIENT.

    Description of Event or Problem · 1

    A SIMPLE PERFORATION OF THE DIAPHRAGM OCCURRED DURING A DIAPHRAGM STRIPPING AS A RESULT OF INTENSIVE USE OF THE HANDPIECE OVER THE SAME SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504659 SINGLE-USE CUT/COAG HANDPIECE FOR OPEN SURGERY GEI PLASMA SURGICAL INC. OS-CG 05-12H RG400001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention