BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICEROD PLUS 90 MULTIPACK

    MDR report key: 3130265 · Received May 22, 2013

    Report

    Report Number
    9616793-2013-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K110946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A CRYABLATION PROCEDURE, AN ICEROD PLUS NEEDLE DEVELOPED FROST ALONG THE NEEDLE SHAFT DURING THE FIRST FREEZE CYCLE. THE NEEDLE WAS REPLACED WITH A NEW ONE. THE CASE WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227263 ICEROD PLUS 90 MULTIPACK CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3509 B0868-005

    Patients

    Seq Age Sex Outcome Treatment
    1