BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEGA

    MDR report key: 3899018 · Received May 19, 2014

    Report

    Report Number
    3008812068-2014-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CRYOCONCEPTS LP
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014. THE CRYOMEGA DEVICE WAS RECEIVED DISASSEMBLED. ADD' L LOT # 3012.

    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. THE PHYSICIAN REPORTED THAT ON (B)(6) 2014, WHEN SHE WENT TO ACTIVATE THE UNIT, SHE FELT SOME CRYOGEN ESCAPE FROM THE DEVICE, THEN THE UNIT BLEW APART WITH THE CYLINDER FLYING AND HITTING AN EMPLOYEE IN THE HEAD. THE PHYSICIAN STATED THAT SHE USED THE DEVICE ON (B)(6) 2014 AND EXPERIENCED NO PROBLEMS. THE EMPLOYEE HAS A HEADACHE. THE PHYSICIAN INDICATED THAT THEY ICED THE EMPLOYEE'S TEMPLE AREA AND SENT HER HOME EARLY WITH MEDICATION FOR A HEADACHE ON (B)(6) 2014. THE PATIENT CONTINUED TO HAVE A HEADACHE DURING THE WEEK AND A CT SCAN WAS PERFORMED ON (B)(6) 2014. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295865 CRYOMEGA CRYOSURGICAL UNIT AND ACCESSORIES GEH CRYOCONCEPTS LP NA 3009

    Patients

    Seq Age Sex Outcome Treatment
    1