BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVERA CRYGENIC UNIT

    MDR report key: 15233279 · Received August 15, 2022

    Report

    Report Number
    MW5111471
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 11, 2022
    Manufacturer
    PACIRA PHARMACEUTICALS, INC.
    Product Code
    GXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARTRIDGE SHOT OFF END OF MACHINE. PRIOR TO THE PROCEDURE WITH PATIENT IN ROOM, THE CARTRIDGE ON THE HAND PIECE WAS FORCEFULLY EXPELLED RESULTING IN PHYSICIAN BEING HIT IN ARM BY CARTRIDGE. NO HARM TO PATIENT. THE DEVICE HAD AN ERROR CODE FOLLOWING EVENT. DEVICE WAS REMOVED FROM SERVICE AND SENT TO CLINICAL ENGINEERING. THE CARTRIDGE WAS INADVERTENTLY DISCARDED. THE ERROR CODE LIGHTS INDICATED "AN UNRECOVERABLE ERROR HAS OCCURRED". AFTER FOLLOWING THE MANUFACTURER'S RECOMMENDATION TO RESET THE ERROR AND TEST THE DEVICE, OUR CLINICAL ENGINEERING TEAM COULD NOT DUPLICATE THE ERROR. THIS DEVICE WILL NOT GO BACK INTO SERVICE, LOVERA IS REPLACING THE FAILED DEVICE WITH AN UPDATED VERSION OF THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819403 LOVERA CRYGENIC UNIT DEVICE, SURGICAL, CRYOGENIC GXH PACIRA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other