BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEST FIBER

    MDR report key: 8147755 · Received December 10, 2018

    Report

    Report Number
    1063481-2018-00052
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 12, 2018
    Report Date
    January 9, 2019
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS LOST DURING SHIPMENT. A CLAIM HAS BEEN OPEN WITH THE SHIPPING COMPANY. SHOULD THIS PACKAGE BE FOUND AN INVESTIGATION AND A FOLLOW-UP REPORT WILL BE PERFORMED. THE SERIAL NUMBER THAT WAS INITIALLY PROVIDED IS NOT AN ACCURATE SERIAL NUMBER THEREFORE NO MANUFACTURING REVIEW COULD BE MADE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "DOING AN INSERVICE WITH THE HOSPITAL TEST FIBER, THE FIBER SPARKED AND SMELLED LIKE BURNING."

    Additional Manufacturer Narrative · 1

    AWAITING SAMPLE RETURN, ONCE RECEIVED, AN EVALUATION WILL BE PERFORMED. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, "DOING AN INSERVICE WITH THE HOSPITAL TEST FIBER, THE FIBER SPARKED AND SMELLED LIKE BURNING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986248 TEST FIBER SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION MNO CRYOLIFE, INC. ACC-FIBR

    Patients

    Seq Age Sex Outcome Treatment
    1