BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML-10 MUTI-FIRE CLIP APPLIER

    MDR report key: 7560009 · Received June 1, 2018

    Report

    Report Number
    1223422-2018-00015
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 8, 2018
    Report Date
    June 1, 2018
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GCJ
    UDI-DI
    00811099010388
    PMA / PMN Number
    K013695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ML-10 CLIP APPLIER, DEVICE WAS RETURNED WITH DAMAGES TO ITS JAWS. THERE WERE MARKINGS ON THE UPPER RIGHT JAW ,RIGHT MID JAW, AND LEFT TOP JAW. THIS ALSO INDICATES THAT THE DEVICE HAD EXPERIENCED SOME TYPE OF EXTERNAL FORCE, POSSIBLY DURING PROCESSING, AND OR STERILIZATION. BECAUSE OF THE CONDITION OF THE RETURNED DEVICE, AN ACTUAL FUNCTIONAL COULD NOT BE PERFORMED. FOR FINAL INSPECTION REQUIREMENTS, ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IMPERFECTIONS. IT IS NOT LIKELY THAT THE DEVICE LEFT MICROLINE SURGICAL, INC., IN THIS CONDITION. A POTENTIAL ROOT CAUSE OF THIS ISSUE, WAS DETERMINED AS AN IS EXCESSIVE FORCE APPLIED TO THE JAWS OF THE ML-10 CLIP APPLIER DEVICE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO MICROLINE. NO INVESTIGATION CAN BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, WHEN THE DOCTOR ATTEMPTED TO USE THE CLIP APPLIER, HE NOTICED THAT WHEN HE TRIED TO RELEASE THE JAWS OF THE CLIP APPLIER, THE CLIP DID NOT DISENGAGE FROM THE CLIP APPLIER. HE STATED THAT THE NOW COMPRESSED CLIP WAS PULLED ACROSS THE BLOOD VESSEL HE HAD CLOSED. HE STATED THERE WAS TISSUE DAMAGE TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404006 ML-10 MUTI-FIRE CLIP APPLIER CLIP IMPLANTABLE GCJ MICROLINE SURGICAL INC. 1002 00121555 00811099010388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other