BEUDAMED
    FDA Adverse Event Summary report: N

    5MM VISULOC MULTI-FIRE SPRING CLIP APPLIER

    MDR report key: 6288190 · Received January 30, 2017

    Report

    Report Number
    1223422-2017-00006
    Date Received
    January 30, 2017
    Date of Event
    November 14, 2016
    Report Date
    January 30, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    FZP
    PMA / PMN Number
    K033161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 5 MM VISULOC MULTI-FIRE SPRING CLIP APPLIER WAS RETURNED TO MICROLINE SURGICAL, INC., FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED IN ITS ORIGINAL PACKAGING. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND EVALUATED FOR MECHANICAL FUNCTIONALITY. THE DEVICE FUNCTIONED AS INTENDED. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THERE WAS NO HARM TO THE PATIENT. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR (PAST 30-DAYS) DUE TO THE STAFF RESPONSIBLE FOR THE INVESTIGATION LEAVING, AND LACK OF STAFF TO COMPLETE THE TASK, INCLUDING LACK OF FULL INFORMATION AVAILABLE ON THE COMPLAINT TO SUBMIT THE MDR. MICROLINE SURGICAL, INC., WILL CONTINUE TO ENSURE ITS DUE DILIGENCE IN POST-MARKET COMPLAINTS HANDLING, AND ENSURING THAT ALL REQUIREMENTS FOR THE MEDICAL DEVICE EMDR REPORTING HAVE BEEN MET.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, USING 5 MM VISULOC MULTI-FIRE SPRING CLIP APPLIER, TWO SPRING SLIPS SLIPPED OFF AND FELL INTO THE PATIENT. THE CLIPS WERE REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68907 5MM VISULOC MULTI-FIRE SPRING CLIP APPLIER CLIP, IMPLANTABLE FZP MICROLINE SURGICAL, INC. 2001 00128993

    Patients

    Seq Age Sex Outcome Treatment
    1 Other