BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 6022662 · Received October 12, 2016

    Report

    Report Number
    2031527-2016-00476
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009011381
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. DEVICE WAS NOT RETURNED AND THEREFORE SAMPLE EVALUATION WAS NOT ABLE TO CONFIRM THE REPORTED EVENTS. ALL REPORTED FOLLOW-UP INFORMATION IN THIS REPORT WAS PREVIOUSLY SUBMITTED TO THE FDA ON 07/25/2017 UNDER INCORRECT MFR# 2031527-2017-00476 FOLLOW-UP 001. THE FOLLOW-UP INFORMATION SHOULD HAVE BEEN SUBMITTED UNDER THIS MFR# 2031527-2016-00476 FOLLOW-UP 001.

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AT THE COMPLETION OF THE INITIAL IMPLANT OF AFX DEVICES, A LONG PLASTIC STRING WAS OBSERVED COMING FROM THE INTRODUCER DEVICE WHEN REMOVED FROM THE GROIN AREA OF THE PATIENT. THE IMPLANT PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674869 AFX INTRODUCER MIH ENDOLOGIX INC. S17-45 1497635-015 00818009011381

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other