BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED LONG

    MDR report key: 2091874 · Received May 17, 2011

    Report

    Report Number
    3005075853-2011-02013
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED WITH THE BODY LATCH MECHANISM BROKEN MAKING THE INSTRUMENT NON-FUNCTIONAL. IN ADDITION, THE CARTRIDGE COVER WAS NOTED CRACKED AT DISTAL END. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE DEVICE IS NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE CARTRIDGE COVER MAY LEAD DROPPING/EJECTED CLIPS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SURGERY FOR A TUMOR AT THE CHEST WALL, WHEN THE HANDLE WAS GRASPED, THE CLIP WAS NOT FORMED AND FELL OUT WITH THE NEXT CLIP INSIDE THE PATIENT'S BODY AT ABOUT THE 10TH FIRING. THE FALLEN CLIPS WERE RETRIEVED AND NO PIECES WERE LEFT INSIDE THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE JUST IN CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED LONG CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1