BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESICE ICEROD PROSTATE KIT

    MDR report key: 1880107 · Received June 17, 2010

    Report

    Report Number
    9616793-2010-00007
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K060390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PROSTATE CRYOTHERAPY PROCEDURE IN (B)(6), THE PHYSICIAN COMPLETED ONE FREEZE CYCLE WITH A PASSIVE THAW AND AN ACTIVE THAW. DURING THE SECOND FREEZE CYCLE, THE NEEDLES DID NOT FREEZE. THE USER TRIED TO STOP AND RESTART THE FREEZE CYCLE AND ALSO CHANGED THE POSITION OF THE NEEDLES TO ANOTHER CHANNEL, BUT THE PROBLEM WAS NOT RESOLVED. TWO ICEROD ITHAW NEEDLES WERE USED. NO ERROR MESSAGES WERE DISPLAYED. THEY WERE ABLE TO FINISH THE CASE BUT THE PROSTATE WAS NOT TOTALLY TREATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESICE ICEROD PROSTATE KIT GEH GALIL MEDICAL LTD. FPRPR4070 G5629-002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK