BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ML-10 MULTI-FIRE CLIP APPLIER

    MDR report key: 6451329 · Received March 31, 2017

    Report

    Report Number
    1223422-2017-00031
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    November 17, 2017
    Report Date
    March 31, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN INVESTIGATION COULD NOT BE COMPLETED AT THE TIME OF THIS MDR SUBMISSION. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR 1223422-2017-00031 (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 MANUFACTURER.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, SURGICAL PROCEDURE, THE SURGEON APPLIED THE CLIP CARTRIDGE TO THE ML-10 MULTI-FIRE CLIP APPLIER, THE FIRST CLIP BLOCKED INTO THE JAW AND CAUSED JAMMING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231688 ML-10 MULTI-FIRE CLIP APPLIER REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS GCJ MICROLINE SURGICAL, INC. 1002 00132118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other