BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICESPHERE 1.5 CX 90 DEGREE

    MDR report key: 15289012 · Received August 24, 2022

    Report

    Report Number
    2134265-2022-08655
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    November 13, 2022
    Manufacturer
    BTG YOKNEAM
    Product Code
    GEH
    UDI-DI
    07290104831133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 - MANUFACTURER ADDRESS 1: (B)(4). DEVICE EVAL BY MANUFACTURER: VISUAL ANALYSIS OF THE NEEDLE SHOWED NO OBVIOUS DAMAGE. THE NEEDLE WAS LEAK AND PERFORMANCE TESTED. AN AIR LEAK WAS SEEN FROM THE HANDLE-SHAFT CONNECTION. THE SHRINK WRAP WAS REMOVED FROM THE HANDLE, AND MICROSCOPIC ANALYSIS OF THIS CONNECTION SHOWED A LACK OF GLUE.

    Additional Manufacturer Narrative · 0

    D3 - MANUFACTURER ADDRESS 1: TAVOR BUILDING 1, INDUSTRIAL PARK.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE GAS LEAK OCCURRED. DURING PREPARATION FOR A RENAL CELL CARCINOMA (RCC) TREATMENT PROCEDURE, INTEGRITY TESTING OF AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE REVEALED A GAS LEAK AT AN UNKNOWN LOCATION. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE GAS LEAK OCCURRED. DURING PREPARATION FOR A RENAL CELL CARCINOMA (RCC) TREATMENT PROCEDURE, INTEGRITY TESTING OF AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE REVEALED A GAS LEAK AT AN UNKNOWN LOCATION. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE LEAK WAS COMING FROM THE GREY TUBE TO HANDLE JOINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE GAS LEAK OCCURRED. DURING PREPARATION FOR A RENAL CELL CARCINOMA (RCC) TREATMENT PROCEDURE, INTEGRITY TESTING OF AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE REVEALED A GAS LEAK AT AN UNKNOWN LOCATION. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE LEAK WAS COMING FROM THE GREY TUBE TO HANDLE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460366 ICESPHERE 1.5 CX 90 DEGREE UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG YOKNEAM FPRPR3573 0029221056 07290104831133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown