BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEDNET CRYOABLATION SYSTEM

    MDR report key: 2060852 · Received March 11, 2011

    Report

    Report Number
    9616793-2011-00004
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K011950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PREVENTIVE MAINTENANCE WAS PERFORMED ON THE SYSTEM AND THE SYSTEM WAS FOUND TO BE IN PROPER WORKING ORDER. THE THERMAL SENSOR THAT WAS PROVIDING ERRATIC READINGS WAS NOT RETURNED AND, THEREFORE, COULD NOT BE INVESTIGATED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PHYSICIAN DID NOT FEEL THAT THE ICE GOT COLD ENOUGH. IT IS UNK IF THE PHYSICIAN WILL RETREAT THE PT.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN AT (B)(6) HOSPITAL CALLED IN AN ISSUE. HE INDICATED THAT THEY CHANGED THE PROBES MULTIPLE TIMES AND THE NEEDLES DID NOT GET COLD ENOUGH. THE MOBILE PROVIDER STATED THAT IN HIS OPINION: THE SYSTEM WORKED FINE. PASSED TEST, MADE VISIBLE ICE ON ULTRASOUND. THERMAL SENSORS DID NOT SHOW COLD TEMPERATURES AS THE DOCTOR WOULD LIKE TO SEE BECAUSE (IN THE MOBILE PROVIDER'S OPINION), DOCTOR DID NOT FREEZE LONG ENOUGH AND PLACED THERMAL SENSORS MAY HAVE BEEN TOO FAR AWAY FROM PROSTATE, ALTHOUGH ONE THERMAL SENSOR DID GIVE ERRATIC TEMPERATURE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDNET CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRCH2024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK