BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M/L-10

    MDR report key: 3840264 · Received April 22, 2014

    Report

    Report Number
    3840264
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICROLINE SURGICAL, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE USING A MICROLINE SURGICAL M/L-10 CLIP APPLIER THE METAL PIECE BROKE OFF. IT WAS RETRIEVED AND PASSED OFF OF THE FIELD. IT IS AN INSTRUMENT TO APPLY CLIPS TO VESSELS AND OTHER TISSUES TO STOP BLEEDING. THIS INSTRUMENT HAS A HANDLE LIKE PLIERS THAT HAS A METAL PIECE IN BETWEEN THE 2 HANDLES. THAT PIECE HELPS THE INSTRUMENT RETURN TO ITS ORIGINAL POSITION BEFORE FIRING AGAIN. THAT PIECE IS THE PIECE THAT BROKE OFF DURING THE PROCEDURE AND WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242298 M/L-10 APPLIER, SURGICAL, CLIP GCJ MICROLINE SURGICAL, INC * 1996048

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR