BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSOLUTIONS 1PK CARTRGE

    MDR report key: 21297604 · Received February 3, 2025

    Report

    Report Number
    3014334038-2025-00008
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 26, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GEH
    UDI-DI
    10381780171973
    PMA / PMN Number
    K091721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATIONS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CRYOSOLUTIONS 1PK CARTRIDGE (33518) WAS NOT RETURNED TO THE MANUFACTURER AFTER THREE GOOD FAITH EFFORT (GFE) ATTEMPTS TO RETRIEVE THE PRODUCT. LOT NUMBER INFORMATION WAS PROVIDED; DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WAS OBSERVED. THUS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF GAS COMING OUT MAY BE THE RESULT OF DAMAGE TO THE O-RING ON THE CUSTOMER'S CONTROL UNIT OR INCOMPLETELY INSTALLING THE CARTRIDGE. THE CUSTOMER IS DIRECTED TO FOLLOW THE CRYOSOLUTIONS INSTRUCTIONS FOR USE (IFU) FOR APPROPRIATE ASSEMBLY AND HANDLING.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT WHEN THEY WENT TO USE THE CRYOSOLUTIONS 1PK CARTRIDGE (33518) ALL THE GAS CAME OUT. THERE HAVE BEEN NO REPORTS OF PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294179 CRYOSOLUTIONS 1PK CARTRGE M3 GEH INTEGRA LIFESCIENCES MANSFIELD 7358183 10381780171973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown