BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** MCA

    MDR report key: 1862647 · Received October 8, 2010

    Report

    Report Number
    3005075853-2010-05784
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A CORONARY ARTERY BYPASS GRAFT PROCEDURE WHEN THE SURGEON HARVESTED THE SAVENOUS VEIN, THE DEVICE JAMMED AND HE COULD NOT FIRE THE DEVICE. HE USED A SECOND CLIP APPLIER TO CONTINUE THE PROCEDURE. THE PATIENT HAD BEEN IN RECOVERY FOR 4-5 HOURS WHEN THE ATTENDING NURSE NOTICED EXCESSIVE BLOOD IN THE DRAIN; THE SURGEON DECIDED TO RETURN THE PATIENT TO THE OPERATING ROOM AND PERFORM AN ADDITIONAL SURGERY. WHEN HE OBSERVED THE VEIN SITE THERE WAS A MISSING CLIP AND THE CLIP LINE WAS LEAKING. THE SURGEON THEN SUTURED OVER THE CLIP LINE TO STOP THE LEAK. THE PATIENT REQUIRED 2 UNITS OF BLOOD AND ADDITIONAL TIME IN ICU. PATIENT HAS NOW BEEN RELEASED HOME AT THIS TIME. DEVICE WAS DISCARDED AT THE ACCOUNT EARLIER THAT DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention