BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CLIP APPL/REMVR 210 MM VARIABLE

    MDR report key: 3042889 · Received April 4, 2013

    Report

    Report Number
    1045834-2013-01355
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE "LATCH IN THE MIDDLE IF THE DEVICE WAS STUCK IN THE LOCK POSITION AND WOULD NOT RELEASE." THE REPORTER WAS UNABLE TO CONFIRM WHETHER OR NOT THE DEVICE WAS BEING USED DURING PRETESTING SET UP FOR AN ANEURYSM SURGERY OR IF DISCOVERED DURING SURGERY. IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138484 L-CLIP APPL/REMVR 210 MM VARIABLE HCI THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1