BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2111805 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02248
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 10, 2011
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SALES REP SPOKE TO THE SURGEON TO INQUIRE HOW HIS PATIENT WAS DOING AND HE INDICATED THE PATIENT WAS DOING FINE. HE DID MENTION, ALTHOUGH NOT SURE, THAT THERE MAY HAVE BEEN A STONE IN THE CBD THAT COULD HAVE CONTRIBUTED TO THE POST-OP LEAK.

    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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PATIENT HAD A POST OP LEAK AT THE CYSTIC DUCT. IT IS UNKNOWN HOW MANY DAYS POST OP THE LEAK WAS DISCOVERED. IT IS UNKNOWN IF OTHER DIAGNOSTIC TESTS WERE PERFORMED. A STENT WAS PLACED IN THE PATIENT AND THE PATIENT IS CURRENTLY OKAY. DURING THE ORIGINAL CASE THE DEVICE FIRED FINE AND THERE WERE NO NOISES. THE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention