BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX 5MM

    MDR report key: 3934262 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04944
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    November 1, 2013
    Report Date
    June 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DURING AN ACUTE CHOLECYSTITIS LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED TO PLACE THREE CLIPS ON THE PATIENT SIDE AND ONE ON THE SPECIMEN SIDE. POST-OP THE PATIENT PRESENTED WITH A CYSTIC STUMP DUCT LEAK. AN ERCP. STENT WAS REQUIRED TO ADDRESS THE LEAK. THE PATIENT IS NOW DOING FINE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413471 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention