BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOMATIC

    MDR report key: 5123513 · Received October 2, 2015

    Report

    Report Number
    5123513
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 28, 2015
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Product Code
    HRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING RIGHT EYE PNEUMATIC RETINOPEXY TO REPAIR RIGHT RETINAL DETACHMENT. REPORTEDLY, THE CRYOPROBE HAD BEEN CHECKED BY STAFF PRIOR TO PROCEDURE AND FOUND TO FROST/DEFROST APPROPRIATELY. PER MEDICAL RECORD, APPROXIMATELY THREE TO FOUR CRYOTHERAPY SPOTS WERE PLACED AROUND THE RETINAL TEAR WITHOUT INCIDENT. HOWEVER, ON THE FOURTH ACTIVATION THE PROBE WOULD NOT DEFROST FOLLOWING DEACTIVATION OF THE FOOT PEDAL AND COULD NOT BE REMOVED. REPORTEDLY, THIS RESULTED IN A PROLONGED FREEZE. SURGEON THEN PLACED COUNTERTRACTION ON THE GLOBE IN ORDER TO REMOVE THE PROBE. PATIENT SUSTAINED A CONJUNCTIVAL LACERATION WHICH WAS REPAIRED WITH TWO SUTURES. THE CRYOMACHINE WAS TAKEN OUT OF SERVICE AND REPLACED WITH A SECOND MACHINE. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652211 CRYOMATIC UNIT, CRYOPHTHALMIC, AC-POWERED HRN KEELER INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention