BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ML 10 CLIP APPLIER

    MDR report key: 3983406 · Received July 7, 2014

    Report

    Report Number
    1223422-2014-00019
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    April 12, 2013
    Report Date
    July 3, 2014
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE A PIECE OF CLIP APPLIER METAL TIP BROKE OFF AND FELL INTO THE PT. THE PIECE WAS RETRIEVED. THE PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395172 ML 10 CLIP APPLIER REUSABLE LAPAROSCOPIC CLIP APPLIER GCJ MICROLINE SURGICAL, INC. 1002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention