BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS

    MDR report key: 6517432 · Received April 24, 2017

    Report

    Report Number
    1223422-2017-00058
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    December 7, 2017
    Report Date
    April 24, 2017
    Product Code
    FZP
    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 RETURNED TO THE MANUFACTURER, AND AN INVESTIGATION IS PENDING (NOT COMPLETED) AT THE TIME OF THIS MDR SUBMISSION. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR 1223422-2017-00058 (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. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    DURING A SLEEVE GASTRECTOMY/BY PASS/CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LAST CLIP IN THE CLIP CARTRIDGE OF THE ML-10 CLIP APPLIER, DID NOT RELEASE. ANOTHER CLIP CARTRIDGE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE AND THE ANESTHESIA TIME WAS EXTENDED BY TEN (10) MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297349 REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS CLIPS IMPLANTABLE FZP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other