BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCISE EZ VIEW

    MDR report key: 4801138 · Received May 26, 2015

    Report

    Report Number
    3006524618-2015-00079
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 30, 2015
    Report Date
    November 9, 2015
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THREE DEVICES WERE FUNCTIONALLY TESTED AND PERFORMED WITHIN SPECIFICATIONS. THE COMPLAINANTS COULD NOT BE VERIFIED, NOR COULD A ROOT CAUSE BE DETERMINED WITH CONFIDENCE SINCE THE DEVICES THAT WERE RETURNED FOR EVALUATION ALL PERFORMED TO SPECIFICATION. FACTORS UNASSOCIATED WITH THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD CONTRIBUTE TO SUCTION LINE CLOGGING INCLUDE: INSUFFICIENT SOURCE VACUUM AT THE USER FACILITY ATTEMPTING TO SUCTION LARGE TISSUE PARTICLES THROUGH THE DEVICE SUCTION LUMEN USING THE DEVICE SUCTION LUMEN AS THE SOLE SOURCE OF FLUID EXTRACTION. FACTORS UNASSOCIATED WITH THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD CONTRIBUTE TO INABILITY TO STOP OR CONTROL BLEEDING INCLUDE: USE OF COAGULATION SETTINGS BELOW THE DEFAULT SET POINT SURGICAL TECHNIQUE; PATIENT FACTORS, INCLUDING MEDICATIONS WHICH MAY LIMIT THE ABILITY OF BLOOD CLOTTING. INADVERTENT USE OF THE ABLATION FOOT CONTROL SWITCH WHEN COAGULATION IS INTENDED. THE IFU CONTAINS SUFFICIENT WARNINGS AND PRECAUTIONARY STATEMENTS REGARDING MAINTAINING PROPER SUCTION FLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING A PROCISE EZ VIEW WAND, THE PATIENT EXPERIENCED UNCONTROLLABLE BLEEDING. THE SURGEON WENT THROUGH THREE PROCISE WANDS, YET NONE WERE ABLE TO STOP THE PATIENT'S BLEEDING. THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT OUTCOME OR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339684 PROCISE EZ VIEW ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1087848

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other