BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/L-10 CLIP APPLIER

    MDR report key: 2950218 · Received February 6, 2013

    Report

    Report Number
    1223422-2013-00002
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE M/L-10 CLIP APPLIER WITH A REF 1122 CLIP CARTRIDGE INSIDE WERE RETURNED, DECONTAMINATED AND INVESTIGATED. THE CLIP CARTRIDGE AND OUTER TUBE WERE REMOVED PRIOR TO DECONTAMINATION. THERE WERE NO CLIPS REMAINING IN THE RETURNED CLIP CARTRIDGE INDICATING THAT THE EIGHT SILVER AND TWO BLUE INDICATOR CLIPS WERE FIRED. INITIAL OBSERVATION OF THE RETURNED CLIP APPLIER FOUND THAT THE JAWS WERE BENT OUTWARDS AND OUT OF SPECIFICATION, WHICH IS CONSISTENT WITH MISHANDLING. ALSO, THIS TYPE OF JAW DAMAGE MAY PREVENT THE JAWS FROM PROPERLY RETAINING A CLIP WHILE THE JAWS ARE CLOSING. THE TRIGGER OPERATED FREELY. ALTHOUGH DAMAGE WAS FOUND, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS PRODUCT FIRES A CLIP TO SEAL OFF BLOOD VESSELS, WHEN THE SURGEON FIRED THIS DURING SURGERY THERE WAS NO CLIP AND THE CLIP APPLIER SEVERED THROUGH AN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50661 M/L-10 CLIP APPLIER CLIP APPLIER GCJ MICROLINE SURGICAL 1002R 3074R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention