BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM

    MDR report key: 5442693 · Received February 17, 2016

    Report

    Report Number
    2916714-2016-00099
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    January 20, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K151696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). INTRA OPERATIVE JAWS LOCKED AFTER HEMOSTASIS. DEVICE DOES NOT FINISH ITS COAGULATION CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97454 CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL740SU 52175129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other