BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOICE CRYO-ABLATION PROBE

    MDR report key: 8056965 · Received November 9, 2018

    Report

    Report Number
    3011706110-2018-00217
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    PMA / PMN Number
    K180138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CASE-(B)(4): THE DEVICE WAS RETURNED FOR EVALUATION, DEVICE LOT NUMBER 84256. COMPLAINT IS CONFIRMED FOR TORN MYLAR, SOURCE OF THE TEAR IS A RESULT OF PACKAGING DESIGN AND CUSTOMER HANDLING OF PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. TORN MYLAR WAS DETERMINED DURING INCOMING INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 10/17/2018 THAT THE DISTRIBUTOR RECEIVED A CRYO2 DEVICE THAT FAILED INCOMING INSPECTION FOR THE STERILE PACKAGE BEING TORN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896221 CRYOICE CRYO-ABLATION PROBE CRYOICE CRYO-ABLATION PROBE GXH ATRICURE, INC. CRYOICE CRYO-ABLATION PROBE 84256

    Patients

    Seq Age Sex Outcome Treatment
    1