BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2122221 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02386
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 20, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE SURGEON WAS INSERVICED IN (B)(6) AND AGAIN IN (B)(6) AFTER THE OCCURRENCE OF THIS EVENT. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A SINGLE SITE LAPAROSCOPIC CHOLECYSTECTOMY. THE CASE WAS PERFORMED WITH NO ISSUES, THE PATIENT MAY HAVE BEEN RELEASED. THREE DAYS POST OP, THE PATIENT RETURNED AND IT WAS DIAGNOSED THERE WAS A BILE LEAK. A TEST WAS PERFORMED TO LOCATE THE LEAK. IT IS UNKNOWN IF OR WHAT WAS DONE TO CONTROL THE BILE LEAK. UNKNOWN PATIENT CONSEQUENCE. 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