BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MULTIPLE CLIP APPLIER

    MDR report key: 2123241 · Received June 14, 2011

    Report

    Report Number
    3005075853-2011-02409
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED EMPTY AND LOCKED OUT. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INGUINAL HERNIA PROCEDURE, THE CLIPS WOULD NOT HOLD AFTER PLACING ON THE VEIN. ONE OR TWO CLIP(S) UPON THREE WOULD NOT CLOSE AND HOLD PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA G4UE0G

    Patients

    Seq Age Sex Outcome Treatment
    1