BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM

    MDR report key: 3052972 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01736
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. ADDITIONAL INFORMATION PROVIDED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? RANDOM FIRINGS. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? BREAST PEDICLES. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? YES. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BILATERAL BREAST RECONSTRUCTION PROCEDURE, AS THE SURGEON IS CLOSING THE DEVICE TO FORM THE CLIPS THE FIRING HANDLE IS CATCHING CAUSING THE SURGEON TO FORCE TO FIRE TO BE HIGHER THAN NORMAL. HE IS PULLING ON THE FIRING RING HARDER WHICH IS LEADING TO INCREASED MOVEMENT AT THE JAW OF THE DEVICE WHICH LEADS TO THE SEVERING OF SMALL VESSELS. THE SURGEON FIRES ANOTHER CLIP CLOSER UP THE PEDICLE TO OFFSET THE CUT VESSEL. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156363 LIGACLIP** MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1