BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANLAN THOROSOCOPIC CLAMP

    MDR report key: 4329065 · Received November 13, 2014

    Report

    Report Number
    2126670-2014-00002
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 13, 2014
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K945474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SCANLAN INTERNATIONAL, INC. HAS MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION. NO FURTHER INFORMATION IS AVAILABLE. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE 9909-232-01 CLAMP WAS BEING USED TO CLAMP THE AORTA DURING A MINIMALLY INVASIVE PROCEDURE WHEN IT BROKE. THE SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE TO REESTABLISH CLAMPING OF THE AORTA. THE PROCEDURE WAS THEN COMPLETED. AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731551 SCANLAN THOROSOCOPIC CLAMP THOROSOCOPIC CLAMP GCJ SCANLAN INTERNATIONAL, INC. 9909-232-01 E44

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention