BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM VISULOC MULTI-FIRE SPRING CLIP APPLIER

    MDR report key: 6295264 · Received February 1, 2017

    Report

    Report Number
    1223422-2017-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    October 18, 2016
    Report Date
    February 1, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    FZP
    PMA / PMN Number
    K033161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONED DEVICE WAS DISPOSED INTO BIO-HAZARD BUN AT THE HOSPITAL, THEREFORE THE DEVICE WAS NOT RETURNED TO MICROLINE SURGICAL, INC., FOR AN INVESTIGATION. THERE WAS NO HARM TO THE PATIENT. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR 1223422-2017-00007 (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. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 5MM VISULOC MULTI-FIRE SPRING CLIP APPLIER JAMMED. THE SURGICAL PROCEDURE AND ANESTHESIA TIME WAS EXTENDED FOR 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77719 5MM VISULOC MULTI-FIRE SPRING CLIP APPLIER CLIP, IMPLANTABLE FZP MICROLINE SURGICAL, INC. 2001 00127393

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other