BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE

    MDR report key: 2123201 · Received November 19, 2008

    Report

    Report Number
    9616793-2008-00003
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CASE WAS CANCELLED DUE TO CARD READER ISSUE. THERE WAS NO INJURY TO THE PT. THE CASE WAS RESCHEDULED FOR A LATER DATE. THE DEVICE IS BEING RETURNED TO THE MFR FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

    DURING TESTING PRIOR TO A CASE BEGINNING, THE PRECISE SYSTEM WOULD NOT READ THE BAR CODES FOR THE NEEDLE KIT. THE ERROR MESSAGE WAS "SMART CARD READER INTERNAL ERROR RESET USB CONNECTOR OR USE VALID SMART CARD". THE TECH FOR THE CASE CONTACTED GALIL CUSTOMER SERVICE AND THE SEVERAL ATTEMPTS TO CORRECT THE CARD READING ERROR WERE TRIED. NONE WORKED. THE TECH NOTIFIED THE OPERATING ROOM STAFF ABOUT THE PROBLEM AND LEFT THE ROOM TO CONTINUE TO WORK WITH GALIL CUSTOMER SERVICE BY PHONE. UPON RETURNING TO THE ROOM, THE PT HAD BEEN ANESTHETIZED. AFTER CONSULTATION WITH THE PHYSICIAN, THE CASE WAS CANCELLED. PT WAS RECOVERED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE CRYOSURGICAL UNIT GEH GALIL MEDICAL LTD. FPRCH2047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other