BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMAZE

    MDR report key: 2211227 · Received August 1, 2011

    Report

    Report Number
    2211227
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRYOMAZE WANDS (TIMES 3) WERE GIVEN UP ONTO THE SURGICAL FIELD AND WHEN THE SURGEON BENT THE FLEXIBLE END OF THE WAND, THE OUTER WHITE COVERING CRACKED AND BROKE. THE THREE BROKEN WANDS WERE TAKEN OFF THE FIELD AND PLACED BACK INTO THEIR BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMAZE PROBE, ABLATION, CRYO, CARDIAC OCL MEDTRONIC ATS MEDICAL 60SF2 *
    2 CRYOMAZE PROBE, ABLATION, CRYO, CARDIAC OCL MEDTRONIC ATS MEDICAL 60SF2 *
    3 CRYOMAZE PROBE, ABLATION, CRYO, CARDIAC OCL MEDTRONIC ATS MEDICAL 60SF2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR