BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 3885307 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04170
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE CLIP WAS NOT FULLY ADVANCED INTO THE JAWS AT 2ND OR 3RD FIRING AND A TEARDROP-SHAPED CLIP WAS FORMED. THE DEVICE WAS USED ON THE CYSTIC ARTERY. THE SAME EVENT OCCURRED SEVERAL TIMES. THERE WAS NO UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER. THERE WAS NO UNEXPECTED NOISE. THERE WAS NO TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. THE DEVICE WAS FIRED SEVERAL TIMES OUT OF THE PATIENT AFTER THE EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360632 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1