BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYRO SURGICAL PROBE

    MDR report key: 2345357 · Received April 28, 2011

    Report

    Report Number
    1000391004-2011-00001
    Event Type
    Other
    Date Received
    April 28, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 27, 2011
    Manufacturer
    KEELER LTD.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR NOTIFICATION PURPOSES ONLY, NO ADVERSE INCIDENTS HAVE BEEN REPORTED. A COPY OF THE CORRECT ISSUE IFU AND A TECHNICAL BULLETIN SHALL BE FORWARDED TO ALL USER OF KEELER CYRO PROBES PRODUCED AFTER THE (B)(6) 2010 TO PRESENT DATE. THIS SHALL BE COMPLETED WITHIN 30 DAYS. ALL UNCONTROLLED COPIES OF IFUS HAVE BEEN REMOVED FROM PRODUCTION AND A CAPA # (B)(4) HAS BEEN RAISED TO INVESTIGATE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE FORM HAS BEEN COMPLETED FOR NOTIFICATION PURPOSES, KEELER HAVE NOT RECEIVED ANY NOTIFICATION OF ADVERSE INCIDENTS. A QUERY WAS RAISED FROM (B)(6) REGARDING CONFLICTING INFO SUPPLIED BY KEELER LTD. KEELER LTD HAS RECENTLY UPDATED THE CRYO PROBE USER INSTRUCTION REGARDING THE STERILIZATION METHODS TO BE USED. A TECHNICAL BULLETIN HAD BEEN SUPPLIED TO ALL USERS DESCRIBING THE CHANGES. ON RECEIPT OF NEW PROBES IT WAS NOTED THE INFO WAS CONFLICTING. THE WRONG ISSUE OF USER INSTRUCTION HAS BEEN ATTACHED TO THE PROBES; AS A CONSEQUENCE A METHOD OF STERILIZATION NO LONGER APPROVED BY KEELER MAY HAVE BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYRO SURGICAL PROBE CYRO SURGICAL PROBE GEH KEELER LTD. 2509-P-8000 TO 8006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1