BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCURA CRYOTHERAPY PROBE

    MDR report key: 566186 · Received January 12, 2005

    Report

    Report Number
    566186
    Event Type
    Malfunction
    Date Received
    January 12, 2005
    Date of Event
    November 4, 2004
    Report Date
    January 12, 2005
    Manufacturer
    ONCURA INC
    Product Code
    NFC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT IS IMPORTANT TO NOTE THAT A MFR OF THE DEVICE IN QUESTION (CRYO-HIT SYSTEM) IS GALIL MEDICAL, P.O. BOX 224, YOKNEAM 20692, ISRAEL. ONCURA INC IS A DISTRIBUTOR AND US AGENT OF GALIL MEDICAL, ISRAEL. 1. IN RESPONSE TO THE MED WATCH REPORT RECEIVED ON 2/14/2005, THE DEVICE MFR GALIL MEDICAL SUBMITTED SIX (FOR EACH DEVICE) MEDICATION AND DEVICE EXPERIENCE REPORT - FDA FORM 3500A FOR THIS REPORTED EVENT. THE REPORT NUMBERS SUBMITTED BY GALIL MEDICAL ARE: 9616793-2005-00002, 9616793-2005-00003, 9616793-2005-00004, 9616793-2005-00005, 9616793-2005-00006 AND 9616793-2005-00007. ON THESE REPORTS, THE ROOT CAUSE FOR REPORTED MALFUNCTION WAS IDENTIFIED AS MFG DEFECT - SPECIFICALLY, A PRODUCTION WORKER ERROR. THE PRODUCTION WORKERS WERE MADE AWARE OF THE DEFECTS, INSTRUCTED TO CAREFULLY FOLLOW THE GIVEN INSTRUCTIONS, AND IMPROVE OVERALL QUALITY OF WORKMANSHIP. 2. CONSIDERING THE ROOT CAUSE AS MFG DEFECT, THE DEVICE LABELING DOES NOT RAISE ANY ISSUE OF SAFETY OR EFFECTIVENESS FOR THE SAFE USE THE DEVICE. ALSO, THE DEVICE LABELING HAS NOT SIGNIFICANTLY CHANGED SINCE LAST SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROBLEM IDENTIFIED BEFORE CASE, DURING SET-UP. PROBE DID NOT REGISTER TEMPERATURE, AND COMPUTER DISPLAY READ "NO THERMOCOUPLE READING". SECOND PROBE FROM SAME LOT TRIED, ALSO FAILED. PROBES REPLACED WITH NEW LOT, WHICH WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCURA CRYOTHERAPY PROBE CRYOTHERAPY PROBE NFC ONCURA INC * G0900

    Patients

    Seq Age Sex Outcome Treatment
    1 *