BEUDAMED
    FDA Adverse Event Summary report: N

    CRYOMEGA

    MDR report key: 2987971 · Received January 19, 2013

    Report

    Report Number
    3008812068-2013-00001
    Date Received
    January 19, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 18, 2013
    Manufacturer
    CRYOCONCEPTS LP
    Product Code
    GEH
    PMA / PMN Number
    K102006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/EVALUATION: BACKGROUND: THE CRYOMEGA DEVICE IS ACTIVATED BY FIRST MOVING THE ACTUATION LEVER FORWARD WHICH PIERCES THE NITROUS OXIDE CYLINDER. THE NEXT STEP REQUIRES THE OPERATOR TO "CLICK" THE LEVER DOWN AND LOCK IT INTO PLACE. THE LAST STEP TO ACTUATE AND SPRAY GAS REQUIRES THE OPERATOR TO DEPRESS THE ACTUATOR BUTTON THAT MOVES THE VALVE OPENING THE PATH FOR GAS TO SPRAY. THE UNIT IS NOT TO BE OPENED OR DISASSEMBLED ONCE ACTIVATED. INVESTIGATION: THE CRYOMEGA DEVICE INVOLVED IN THE COMPLAINT WAS RETURNED TO CRYOCONCEPTS LP ON (B)(4) 2012. THE CRYOMEGA DEVICE WAS RECEIVED DISASSEMBLED. VISUAL INSPECTION: THE DEVICE WAS RECEIVED IN TWO PIECES. THE CYLINDER WAS PIERCED AND EMPTIED OF GAS. THE CRACK OCCURRED ON THE RIGHT SIDE END CAP OF THE DEVICE. THE CRACK AT THE BACK OF THE UNIT ON THE BODY APPEARS TO BE THE LOCATION OF THE PLASTICS FAILURE. NO OTHER DAMAGE WAS VISIBLE TO THE OUTER BODY OR THE VALVE.

    Description of Event or Problem · 1

    THE CRYOMEGA IS A DISPOSABLE CRYOSURGICAL DEVICE THAT SPRAYS LIQUID NITROUS OXIDE. THE DEVICE IS RECEIVED BY A HEALTH CARE PROFESSIONAL WITH THE GAS CYLINDER UNPIERCED. TO USE THE UNIT THE OPERATOR PUSHES A LEVER UNTIL THE CYLINDER IS PIERCED AND READY TO SPRAY GAS. A PHYSICIAN WHO WAS A FIRST TIME USE OF A CRYOMEGA DEVICE BEGAN PUSHING ON THE LEVER OF THE DEVICE AND FAILED TO COMPLETE THE MOTION. ACCORDING TO THE USER (THE PHYSICIAN), SHE HAD TO APPLY A GREAT DEAL OF PRESSURE CAUSING THE PLASTIC ON THE DEVICE TO BREAK. WHILE PUSHING THE END TO ACTIVATE THE DEVICE, PART OF THE PRODUCT FLEW ACROSS THE ROOM. THE SPECIFIC COMPLAINT RECEIVED STATED: "A CUSTOMER RECEIVED THE CRYOMEGA AND WAS ATTEMPTING TO ACTIVATE IT, WHILE PUSHING THE END TO ACTIVATE, PART OF THE PRODUCT FLEW OFF AND ACROSS THE ROOM." NO PATIENT WAS INVOLVED AND THERE WAS NO HARM TO THE OPERATOR. FOLLOWING THE INCIDENT THE USER (PHYSICIAN) TOOK ANOTHER UNIT AND PROPERLY ACTIVATED THE UNIT WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28800 CRYOMEGA GEH, CRYOSURGICAL UNIT AND ACCESSORIES GEH CRYOCONCEPTS LP NA 2010-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA