BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIF.CLIP APPL.TI-P 5/310MM F/SM-CLIPS

    MDR report key: 3810505 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00242
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    FZP
    PMA / PMN Number
    K081031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: NO CLIPS WERE RETURNED FOR EVALUATION. THE APPLIER WAS RETURNED AND TESTED WITH TWO MAGAZINES OF CLIPS, THERE WERE NO DEVIATIONS FOUND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). FIVE MM CHALLENGERS CLIPS MISFIRING. NEW APPLICATOR WAS IN USE, ONLY USED ONCE BEFORE. DURING THE CASE, THE CHALLENGER REPEATEDLY MISFIRED, SHOOTING, HALF CLOSED CLIPS INTO THE ABDOMEN AND ALSO WOULD NOT RE-LOAD ANY CLIPS. THERE WAS NO SURGICAL DELAY. THE SURGEON CONTINUED USING ADDITIONAL CLIPS; THE MISFIRED CLIPS WERE NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233390 MULTIF.CLIP APPL.TI-P 5/310MM F/SM-CLIPS VESSEL CLIPS FZP AESCULAP AG & CO. KG PL604R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other